- Email: [email protected]
Local Versus Epidural Anesthesia in Fast-Track Abdominal Aortic Surgery
Local Versus Epidural Anesthesia in Fast-Track Abdominal Aortic Surgery Alessandra Renghi, MD,* Luca Gramaglia, MD,* Francesco Casella, MD,† Diego Moniaci, MD,† Katia Gaboli, MD,* and Piero Brustia, MD† Objective: The aim of this study was to investigate a possible alternative to epidural anesthesia/analgesia. The authors compared thoracic epidural anesthesia/analgesia with continuous wound infiltration anesthesia/analgesia in patients scheduled for mini-invasive abdominal aortic surgery in a fast-track setting. Design: A prospective randomized study. Setting: A university hospital. Participants: Sixty patients undergoing fast-track abdominal aortic surgery. Interventions: The authors compared thoracic epidural infusion (the PERI group) with continuous local wound infiltration (the LOC group) for anesthesia/analgesia. Pain scores, the resumption of oral feeding, the resumption of ambulation, the day of discharge, and postoperative complications in the immediate (ie, 30 days) and long-term periods (ie, 2 years) were evaluated. Measurements and Main Results: Pain scores were low in both groups. The intraoperative LOC group needed higher
doses of anesthetic/analgesic drugs. The postoperative LOC group needed significantly higher doses of bupivacaine (3.9 ⴞ 0.7 mL/h [PERI group] and 5.7 ⴞ 1.3 mL/h [LOC group] on day 0 [p < 0.01]; 3.8 ⴞ 0.8 mL/h [PERI group] and 5.3 ⴞ 1 mL/h [LOC group] on day 1 [p < 0.01]). The parameters of postoperative recovery were comparable between the 2 groups in terms of the resumption of ambulation after surgery (within 3 hours), feeding (within 6 hours), the passage of stools (mean 2 days), and the median hospital stay (3 days). In the 2-year follow-up period, a difference between the 2 groups in the incidence of wound complications was not observed. Conclusions: The results obtained showed good and similar pain control in the 2 groups, but the LOC group required higher doses of anesthetic/analgesic drugs. Parameters of the postoperative recovery were similar in both groups. © 2013 Elsevier Inc. All rights reserved.
F
5 cm or larger in diameter was recommended. Our anesthesiological and surgical team started a program to offer a mini-invasive approach to all patients affected by abdominal aortic aneurysms in an attempt to make this a viable option for patients not eligible for endovascular abdominal aneurysm repair because of unfavorable anatomy, age under 65 years, and aortoiliac occlusive disease. Exclusion criteria included the following: the need for emergency care, the need for retroperitoneal surgical access, and patient refusal. Patients with a history of chronic analgesic drug usage also were excluded from the study. The schedule for randomization was generated randomly using a computer before the initiation of the trial. The allocation of patients was performed with concealed and opaque numbered envelopes. An independent staff member prepared the envelopes. The envelopes were opened by anesthesiologists immediately before surgery. The mini-invasive surgical approach consisted of the following: a left subcostal mini-incision, transperitoneal access without evisceration, and no use of drains or nasogastric tubes. The patient was placed in a dorsal decubitus position to perform midline or transverse laparotomy. The cutaneous incision of 10 to 15 cm, depending on the abdominal size, was parallel to the chondrocostal edge and the spread from the linea alba to the edge of the rectus muscle. The cutaneous incision crossed the linea alba about halfway between the xiphoid and the umbilicus depending on the extension of the aortoiliac aneurysmal disease. The incision of the rectum muscle allowed access to the abdominal cavity. The oblique and transverse muscles were spared. The bowel was maintained within the abdominal cavity. Usually, the self-retaining retractors are not used in order to avoid wall strain and minimize postoperative pain. The abdominal wall and the bowel were retracted gently with moistened towels maintained by the blade of
AST-TRACK SURGERY procedures aim to reduce perioperative stress to improve postoperative recovery.1 A cornerstone of these programs is achieving optimal pain relief.2 With abdominal surgery, including abdominal aortic surgery, there are consistent reports of the efficacy of thoracic epidural anesthesia/analgesia in terms of optimal pain relief and better postoperative outcomes.3 However, this technique requires an increased amount of supervision and is not free from potential risks, primarily the risk of epidural hematoma in patients receiving unfractionated heparin.4 The aim of this study was to investigate a possible alternative to epidural anesthesia/analgesia. Continuous wound infiltration is less invasive although it exposes patients to the risk of surgical wound complications.5,6 The present authors compared thoracic epidural anesthesia/analgesia with continuous wound infiltration anesthesia/analgesia in patients scheduled for miniinvasive abdominal aortic surgery in a fast-track setting. The first endpoint consisted of comparing trends of postoperative pain between the 2 groups. Moreover, the main determinants of the postoperative outcome and the incidence of complications in the immediate postoperative period and in the 2-year follow-up period were compared. This prospective randomized study was conducted to test the hypothesis that thoracic epidural analgesia provides better postoperative pain control and a quicker recovery in the postoperative period compared with continuous wound infiltration with a local anesthetic. METHODS A prospective randomized study was conducted on 60 consecutive patients scheduled for elective mini-invasive abdominal aortic surgery in a fast-track setting. The patients were enrolled at the Vascular Surgery Department, University Hospital “Maggiore della Carità,” Novara, Italy, between February 1, 2005, and February 1, 2006. The study was designed according to the Declaration of Helsinki principles. The study project was submitted to and approved by the Inter-Hospital Ethics Committee of Novara. Each patient signed a written consent form before participation in the study. Elective aneurysm repair for patients with an infrarenal abdominal aortic aneurysm
KEY WORDS: blended anesthesia, fast-track aortic surgery, postoperative outcome, local anesthesia, epidural anesthesia
From the Departments of *Anaesthesia and †Vascular Surgery, University Hospital “Maggiore della Carità,” Novara, Italy. Address reprint requests to Alessandra Renghi, MD, University Hospital “Maggiore della Carità,” Corso Mazzini, 18, 28100 Novara, Italy. E-mail: [email protected] © 2013 Elsevier Inc. All rights reserved. 1053-0770/2703-0001$36.00/0 http://dx.doi.org/10.1053/j.jvca.2012.09.026
Journal of Cardiothoracic and Vascular Anesthesia, Vol 27, No 3 (June), 2013: pp 451-458
451
452
RENGHI ET AL
intestinal retractors. The next surgical steps were performed according to traditional methods. At the end of the surgery, the patients were transferred directly to the surgical ward where the accelerated rehabilitation protocol started immediately based on early feeding and ambulation. All patients underwent blended anesthesia, which included general and peripheral anesthesia. Based on the results from the randomization, the patients were assigned to 2 different groups: the epidural thoracic anesthesia/ analgesia group (the PERI group) and the continuous wound infiltration anesthesia/analgesia group (the LOC group). Two hours before surgery, all the patients were transferred to the holding area near the operating room where they were monitored with continuous electrocardiography, oximetry, and invasive measure of arterial pressure (the radial catheter was removed at the end of surgery). Preoperatively, both groups received intravenous administration of proparacetamol (2 g), metoclopramide (10 mg), fentanyl (100 g), droperidol (2.5 mg), and midazolam (0.02 mg/kg). In both groups, general anesthesia consisted of the following: intravenous administration of titrated propofol (0.5-1.5 mg/kg) and cisatracurium (0.2 mg/kg), placement of a laryngeal mask, mechanical ventilation (tidal volume of 9 mL/kg), maintenance with sevoflurane at a concentration of 0.6% to 1% minimum alveolar concentration, and administration of intravenous ephedrine (10 mg) if the mean blood pressure was lower than 60 mmHg. All the patients received unfractionated heparin at a dose of 50 IU/kg so the activated coagulation time was higher than 200 seconds. During the preoperative period in the PERI group, an epidural catheter was placed at the T6-T7 level, and the patient was given subsequent doses of 2 to 4 mL of levobupivacaine (0.5%) until dermatomeric extension was achieved using the ice test (evaluation of thermal sensibility using ice cubes) equal to T3-S2 (for a maximum total of 25
Enrollment
mL). At the end of surgery, an epidural infusion of levobupivacaine, 0.25% at 4 mL/h, was started for postoperative analgesia. During the preoperative period in the LOC group, the fascia of the parietal peritoneum was infiltrated subcutaneously with 20 mL of levobupivacaine (0.5%). At the end of surgery, subfascial and subcutaneous placement of a double multiperforated catheter was performed, and an infusion of levobupivacaine, 0.25% at 4 mL/h, was started for postoperative analgesia. In the postoperative period, data were collected by doctors and nurses blinded to the analgesic regimen used. To ensure that all personnel were blinded, all patients had identical infusion pumps visible at the shoulder level. Postoperative analgesia was provided with a 48-hour infusion (either an epidural or wound infiltration) of levobupivacaine (0.25% at 4 mL/h). Nurses could make changes within the 2- to 8-mL/h range according to the following criteria: the visual analog scale (VAS) score, which quantifies pain intensity from 0 to 100; mobility recovery; and the patients’ hemodynamic parameters. The maximum dose of levobupivacaine was 400 mg per 24 hours. All patients received oral ibuprofen (600 mg) every 8 hours, and a rescue intravenous dose of ketorolac (30 mg) was available when the VAS was higher than 50. The patients were discharged to home, and the outpatient visits were scheduled 3 and 7 days later. In the follow-up period, the patients were evaluated 3, 6, 12, and 24 months after discharge. The primary outcome measures were related to pain control quality and the parameters of postoperative recovery and included the following: the VAS score at rest and during walking, the dose rate of the epidural or local infusion, the use of supplemental anesthetics or analgesic drugs, the resumption of oral feeding, the resumption of ambulation, and the day of discharge. The secondary outcome measures were related to the hemodynamic perioperative rebound of the
Assessed for eligibility (n=60)
Excluded (n=1) Not meeting inclusion criteria (n=0) Declined to participate (n=0) Other reasons (n=1) Randomized (n=59)
Allocation Allocated to intervention with peridural (n=29) Received allocated intervention (n=29) Did not receive allocated intervention (n=0)
Allocated to intervention with local (n=30) Received allocated intervention (n=30) Did not receive allocated intervention (n=0)
Follow-Up Lost to follow-up (n=0)
Lost to follow-up (n=0)
Discontinued intervention (n=0)
Discontinued intervention (n=0)
Analysis Analysed (n=29) Excluded from analysis (n=0)
Analysed (n=30) Excluded from analysis (n=0)
Fig 1. A diagrammatic representation of the patient distribution.
FAST-TRACK ABDOMINAL AORTIC SURGERY
453
Table 1. Demographic Characteristics and Intraoperative Parameters Intraoperative Period
Women, n (%) Men, n (%) Age, y (mean ⫾ SD) Body mass index (mean ⫾ SD) ASA class 2, n (%) 3, n (%) 4, n (%) Operation length, min (mean ⫾ SD) Clamping length, min (mean ⫾ SD) Hemorrhage, mL (mean ⫾ SD) Diuresis, mL/h (mean ⫾ SD) Total infusions,* mL (mean ⫾ SD) Colloids, mL (mean ⫾ SD) Crystalloids, mL (mean ⫾ SD) Cell saver recovered and transfused blood, mL (mean ⫾ SD) Ephedrine, mg (mean ⫾ SD)
PERI Group (29 Patients)
LOC Group (30 Patients)
3 (10.3) 26 (89.7) 72.2 ⫾ 9.6 25.7 (⫾ 3.6)
2 (6.7) 28 (93.3) 68.9 ⫾ 10 25.2 (⫾ 2.9)
3 (10.3) 15 (51.7) 11 (37.9) 151.7 ⫾ 43.7 71.6 ⫾ 26.1 806.9 ⫾ 655.2 197.5 ⫾ 108.9 2436.4 ⫾ 683.3 613.8 ⫾ 245.3 1548.3 ⫾ 358.7 230.7 ⫾ 248.8 38 ⫾ 27.5
4 (13.3) 23 (76.7) 3 (10) 164.9 ⫾ 53.3 74.1 ⫾ 37.4 736.7 ⫾ 298.8 192.7 ⫾ 104 2354.3 ⫾ 580.4 526.7 ⫾ 170.6 1576.7 ⫾ 389.4 268.7 ⫾ 237.8 18.9 ⫾ 15.3
p Value
0.97 0.21 0.6 0.04
0.31 0.77 0.6 0.86 0.62 0.12 0.77 0.55 0.002
Abbreviations: PERI, thoracic epidural infusion; LOC, continuous local wound infiltration; SD, standard deviation; ASA, American Society of Anesthesiologists. *Colloids ⫹ crystalloids ⫹ cell saver recovered and transfused blood ⫹ autologous transfused blood.
analgesic regimen and postoperative complications. In particular, postoperative complications related to analgesia in the immediate (ie, 30 days) and long-term periods (ie, 2 years) were evaluated. The sample was evaluated using an ␣ error of 0.05 and a power of 80%. The authors assumed an expected difference between the groups of 20 for the VAS (necessary sample equal to 17 patients), 2 hours for the expected return to ambulation (necessary sample equal to 26 patients), 4 hours until the first food intake (necessary sample equal to 6 patients), and 1 day for the time to discharge (necessary sample equal to 17 patients). The randomization, which was created by a computer, was contained in opaque envelopes that were opened upon the patients’ arrival in the operating room. The data were analyzed using Epi Info (Centers for Disease Control and Prevention, Atlanta, Georgia). The nominal variables were described as relative and absolute frequencies, and the differences between the 2 groups were evaluated with the chi-square test. Nonparametric data were expressed as medians with ranges. The variables considered continuous and normally distributed were described as means ⫾ 1 standard deviation. Statistical analysis was conducted using the 2-sided Student t test for normally distributed independent variables. A p value ⬍0.05 was considered significant. RESULTS
Between February 1, 2005, and February 1, 2006, 59 patients were studied. Twenty-nine patients were assigned to the PERI
Fig 2. The intraoperative cardiocirculatory parameters. MBP, mean blood pressure; Hr, heart rate; bas, basal at the arrival in the operating room; induct, after anesthesia induction; preclamp, 5 minutes before abdominal aortic clamping; postclamp, 5 minutes after abdominal aortic clamping; declamp, 5 minutes after abdominal aortic declamping; end, after the patient was awake; p** refers to the difference in the MBP between the PERI group and the LOC group.
group (1 patient was excluded because of the intraoperative detection of pancreatic neoplasia not visualized after the preoperative computed tomography scan), and 30 patients were assigned to the LOC group (Fig 1). The demographic characteristics and intraoperative data are provided in Table 1. The intraoperative use of inotropic drugs was necessary for 3 patients in the PERI group and 2 patients in the LOC group, whereas the use of vasodilators was necessary for 1 patient in the PERI group and 4 patients in the LOC group. Intraoperatively, 1 patient in each group received concentrated erythrocytes. The intraoperative cardiocirculatory parameters are expressed in Figure 2. The minimum alveolar concentration of sevoflurane used during surgery is shown in Figure 3. The intraoperative use of remifentanil was necessary in 4 patients in the PERI group and 27 patients in the LOC group. Figure 4 shows the lower mean blood pressure postoperatively in the PERI group compared with the LOC group; the heart rate was similar in both groups. The removal of the laryngeal mask in the operating room was successful in all cases, and all the patients were transferred to the surgical ward. No patients were admitted to the intensive care unit. In the 48-hour postoperative period, 3 patients in the
454
RENGHI ET AL
Fig 3. The minimum alveolar concentration of sevoflurane.
LOC group experienced hypertensive episodes. No patients in the PERI group experienced postoperative hypertension. The PERI group had a lower (although not significant) VAS score than the LOC group both at rest and when walking, especially on the day of the surgery (Fig 5). The data were confirmed by changes (Table 2) in the rate of the local anesthetic infused (compared with the basal infusion of 4 mL/h) on the day of surgery (day 0) and on the day after surgery (day 1). Despite the greater use of local anesthetics, the patients in the LOC group asked for more analgesic rescue doses of ketorolac (30 mg). In the 24 hours after surgery, 6 patients in the PERI group and 15 patients in the LOC group requested a rescue dose. A rescue dose of subcutaneous morphine (0.1/mg kg) was necessary in 1 patient in the LOC group because the VAS score remained higher than 50 at rest and was equal to 80 when in motion. The primary parameters of postoperative complications in the 2 patient groups are shown in Table 3. No clinically evident pulmonary complications were found throughout the study. Chest radiographic examinations performed on the 2nd day
Fig 4. The postoperative hemodynamic parameters. MBP, mean blood pressure; Hr, heart rate; p** refers to the difference in the MBP in the PERI group versus the MBP in the LOC group. ***Arrival in the surgical ward.
after surgery revealed signs of impaired ventilation at the left pulmonary base (ie, the seat of the surgical mini-incision) in 10 patients in the PERI group and 10 patients in the LOC group. The primary parameters of postoperative recovery in the 2 patient groups are shown in Table 4. On day 0, 6 patients in the PERI group and 3 patients in the LOC group had vomiting episodes. In both cases, it was necessary to give liquid oral medications via an alternate delivery route. In the PERI group, only 1 patient refused dinner compared with 4 patients in the LOC group. All patients ate their meals the following day. No significant differences were observed with regard to the time to the first standing in the 2 groups. The mean VAS score in the PERI group varied from 20 at rest to 30 in motion, whereas in the LOC group the VAS score ranged from 32 at rest to 39 in motion. In both groups, the VAS scores at rest and in motion always were less than 40. The mean blood pressure before the time to the first standing was 80.8 ⫾ 20.4 mmHg in patients in the PERI group and 85.6 ⫾ 11.8 mmHg in the LOC patient group. The mean blood pressure
FAST-TRACK ABDOMINAL AORTIC SURGERY
455
Fig 5. The postoperative VAS. *Arrival in the surgical ward.
after the first standing was 77.1 ⫾ 21.4 mmHg in the PERI group and 82.4 ⫾ 15.9 mmHg in the LOC group. Two years after surgery, all patients were alive and strictly adherent to the follow-up. During this period, 1 patient in each group presented with wound serosity, and 1 patient in the PERI group developed a bulging wound (loosening in the lateral seat of the rectus abdominal muscle). DISCUSSION
Fast-track surgery is a multidisciplinary approach aimed at minimizing perioperative stress determinants to reduce postoperative complications and the time of recovery until “daily normal activities” can be resumed.1 Evidence in fast-track surgery suggests that it is associated with a reduction of costs and the risk of medical complications.7 Since the early 1990s, minimally invasive surgical approaches have been investigated heavily in addition to anesthesiology stress-free techniques and postoperative fast rehabilitation programs.1,2,8 Abdominal aortic surgery is also a realm in which the fast-track approach can improve outcomes, reduce postoperative complications, and reduce the length of hospital stay.3,9-11 However, fast-track abdominal aortic surgery remains the practice of a few specialized centers even if the benefits are well recognized.12 The major components of fast-track methodology are miniinvasive surgery, regional anesthesia and analgesia techniques,
Table 2. Local Anesthetic Infusion Rates on Days 0 and 1
Day 0: infusion of local anesthetic, mL/h (mean ⫾ SD) Day 1: infusion of local anesthetic, mL/h (mean ⫾ SD) Day 0: changes in local anesthetic infusion rates Increase Decrease Day 1: changes in local anesthetic infusion rates Increase Decrease
PERI Group (29 patients)
LOC Group (30 patients)
p Value
3.9 ⫾ 0.7
5.7 ⫾ 1.3
⬍.01
3.8 ⫾ 0.8
5.3 ⫾ 1
⬍.01
3 patients 4 patients
21 patients 2 patients
1 patient 5 patients
3 patients 11 patients
Abbreviations: PERI, thoracic epidural infusion, LOC, continuous local wound infiltration; SD, standard deviation.
and postoperative rehabilitation programs (early feeding and ambulation).2,13 In 2012, Khelet and Slim13 affirmed that regional anesthesia should be used whenever possible. Most fast-track experiences involve the use of thoracic epidural anesthesia and analgesia.2,14,15 Thoracic epidural anesthesia has been used widely to provide excellent pain relief. Thoracic epidural anesthesia attenuates the catabolic response to abdominal surgery; lowers the incidence of pulmonary morbidity; decreases the cardiac metabolic demand; reduces the risk of thromboembolic complications; promotes the recovery of intestinal function; and minimizes motor blockade, thus facilitating early mobilization.2,15-17 In addition, neuroaxial anesthesia reduces intraoperative blood loss.18 Despite these beneficial physiologic effects, the outcome trials still provided uncertain results, probably because the overall perioperative care was not adjusted.15,19 A Cochrane review in aortic surgery concluded that epidural analgesia provides better pain relief and reduces postoperative complications but does not have beneficial effects on postoperative mortality.20 Carli et al2 affirmed that although it might still be difficult to determine how a sole intervention such as regional anesthesia might have an impact on outcome, thoracic epidural anesthesia remains the only regional technique reasonably used in patients undergoing open abdominal fast-track surgery. Unfortunately, this technique requires a large amount of supervision, especially to avoid hypotension and impairment of the lower limbs.21 Watchful monitoring in the postoperative period is essential; pain relief must be tailored to the requirement of each individual patient by monitoring the sensory and motor blockade and the side effects (eg, sedation, hypotension, and early signs of spinal hematoma).22,23 The effective and safe management of epidural analgesia requires that patients are observed systematically by a competent staff.19 Furthermore, in patients on antiplatelet therapy and candidates for systemic intraoperative heparinization, the procedure is not risk free, and some authors advise against its use.4 Since 2006, Kehlet23,24 has invited anesthesiologists to search for analgesic techniques that are as effective as epidural analgesia but less invasive. He himself has evaluated the efficacy of wound infiltration with local anesthetics.5 Wound infiltration with a local anesthetic is a relatively simple technique that provides analgesia by both directly blocking the painful transmission and by inhibiting the local inflammatory response.25 Its efficacy in analgesic terms is controversial in the
456
RENGHI ET AL
Table 3. Postoperative Complications PERI Group
Postoperative complications related to analgesia Day 0
Day 1 Increased troponin levels† Day 0 Day 2
LOC Group
1 hypotension
1 lipothymia* 1 lower limb hyposthenia
1 1 1 1 2 2
hypotension lypothymia lower-limb hyposthenia hypertension lypothymia hypertension
None 5 patients (consistently lower 0.5 ng/mL)
1 patient (0.94 ng/mL) 3 patients: 2 patients had values higher than 1 ng/mL, 1 of whom reached a value of 26 ng/mL‡
1 patient had sinus tachycardia 1 patient had suspected left ventricle overload
1 1 1 1
5 patients
7 patients
152.9 ⫾ 190.4 mg/d
249.4 ⫾ 665 mg/d
Electrocardiographic changes† patient had sinus tachycardia patient had suspected left ventricle overload patient had a small Q wave in D3 patient had a type 1 atrioventricular block with a left bundlebranch block isolated extrasistoles (patient’s troponin level on day 2 was 0.16 ng/mL) 1 patients had sinus tachycardia and signs of previous lower necrosis (the patient’s day 2 troponin level was 26 ng/mL)
Temporary creatinine increases§ Microalbuminuria during the 24 h after surgery (p ⫽ 0.48) Abbreviations: PERI, thoracic epidural infusion; LOC, continuous local wound infiltration. *Transient postural collapse without a loss of consciousness. †Cardiac events were monitored daily with troponin measurements and a 12-lead electrocardiographic record. ‡This patient was successfully treated with specific medical therapy. §Temporary creatinine increases: more than 50% compared with the basal value, which normalized by 4th postoperative day.
literature, especially in major abdominal surgery.2 In a review involving 1,211 patients, Møiniche et al26 concluded that after abdominal surgery there was a lack of evidence regarding the effect of incisional local anesthesia on postoperative pain except for herniotomy. Liu et al25 conducted a meta-analysis including 2,141 patients to determine the efficacy of the continuous infusion of local anesthetic into wounds at the end of surgery and showed that this modality considerably decreased the pain score and the need for opioids. However, the most notable results were in the orthopedic group, and, conversely, in general surgery (including upper abdominal and vascular surgery) the benefits were less evident. In 2001, 50 patients
undergoing major abdominal surgery were enrolled in a prospective study by Fredman et al27 who concluded that bupivacaine wound instillation does not decrease postoperative pain. In a comparative study involving 114 patients undergoing gastric bypass surgery under general anesthesia, Schumann et al28 concluded that infiltration analgesia offers a simple, safe, and inexpensive alternative to epidural pain control. In a recent systematic review, Fustran Guerrero et al29 observed that surgical wound analgesia is effective only in cesarean sections and hysterectomies, and, conversely, the outcomes for other types of surgery are inconsistent. Beaussier et al30 proposed that the continuous preperitoneal administration of ropivacaine after
Table 4. Primary Postoperative Recovery Parameters Parameters
PERI Group (29 Patients)
LOC Group (30 Patients)
p Value
First intake of liquids (hours from the end of surgery) First intake of solids (hours from the end of surgery) First time to stand (hours from the end of surgery) Hours of ambulation when first standing Meters of ambulation when first standing Passage of stool (hours from the end of surgery) Changes in the levels of blood glucose (mg/dL) on day 0 Changes in the levels of blood glucose (mg/dL) on day 1 Mean time to discharge (d)
1.768 ⫾ 1.26 3.5 ⫾ 3 2.37 ⫾ 0.935 0.085 ⫾ 0.036 45.8 ⫾ 21.6 46.7 ⫾ 20.1 137.86 ⫾ 30.76 122.86 ⫾ 26.16 3.2 ⫾ 1.4
1.24 ⫾ 0.475 5.64 ⫾ 6.3 2.596 ⫾ 2.598 0.073 ⫾ 0.028 38.2 ⫾ 18.2 50.7 ⫾ 30.2 144.1 ⫾ 39.88 126.27 ⫾ 25.53 3.4 ⫾ 1.7
0.04 0.11 0.67 0.15 0.16 0.56 0.51 0.63 0.76
Abbreviations: PERI, thoracic epidural infusion; LOC, continuous local wound infiltration.
FAST-TRACK ABDOMINAL AORTIC SURGERY
457
colorectal resection reduced morphine consumption, improved pain relief, and accelerated postoperative recovery despite the fact that a control group of epidural anesthesia was not provided. Only one study involving abdominal aortic surgery did not show that wound instillation with bupivacaine improves pulmonary function or reduces morphine requirements.31 All the experiences did not report side effects (ie, no wound infection or systemic toxicity). Moreover, although it is a simple technique, it presents the following potential risks: the need for high dosages can cause local anesthetic toxicity problems, there is a risk of myotoxicity and myonecrosis, and the Food and Drug Administration emphasizes the risk of local injury in terms of wound infection and necrosis.5,6,27,32 Kehlet and Bay-Nielsen33 assessed 43,123 patients undergoing groin hernia repair and concluded that local anesthesia may be a risk factor for recurrence. Since 2000, the present authors studied fast-track programs in abdominal aortic surgery comprising left subcostal minilaparotomy, thoracic epidural anesthesia/analgesia, and enforced postoperative rehabilitation.34-36 They compared local anesthesia/analgesia with wound infiltration versus thoracic epidural anesthesia for abdominal aortic surgery. The authors sought to verify whether less invasive anesthesia/analgesia compared with thoracic epidural anesthesia/analgesia allows for the maintenance of excellent analgesia and positively impacts the postoperative outcome in terms of reducing complications and accelerating recovery. In the present authors’ experience, the analgesic efficacy of epidural and local anesthesia were comparable. Good VAS values (on a scale from 0 to 100) were observed in both groups. The VAS values were always below 40, except for the VAS values with movement in the LOC group when arriving back from the operating room (VAS ⫽ 44). In the intraoperative period, lower quantities of sevoflurane and remifentanil were used in the PERI group, confirming that epidural analgesia decreases the general anesthetic requirements.37 In the postoperative period, especially in the first 24 hours, significantly higher doses of local anesthetics were necessary in the LOC group. Moreover, the PERI group patients required lower analgesic rescue doses. During the entire perioperative period, a lower mean blood pressure was observed in the PERI group compared with the LOC group, which did not cause an increase in heart rate in the PERI group. Likewise, lower blood pressure values in the PERI group did not influence the time and outcomes related to the time to the first standing.
In the LOC group, a significant increase in troponin values and a greater number of electrocardiographic changes were observed. In fact, epidural anesthesia could have contributed to the reduction of ischemic risks in the perioperative period, as suggested by several previous studies.38 This is notable because troponin increases provide a possible long-term mortality index in vascular patients.39 In the PERI group, lower values of microalbuminuria were observed in the postoperative period. Even if the data are not significant, the data are important to note because microalbuminuria is associated with a decreased prognosis for short- and long-term kidney function after abdominal aortic surgery.40 The present authors did not find any pulmonary complications confirming the use of epidural analgesia in reducing postoperative pulmonary morbidity.41 The parameters of the postoperative recovery were similar in the 2 groups in terms of the resumption of ambulation (within 3 hours after surgery) and feeding (within 2 hours after surgery for liquids and within 6 hours for solid foods), the passage of stools (2nd postoperative day), and the median hospital stay (3 days). At the 2-year follow-up, a difference in wound complication rates was not observed. In the present authors’ experience, the infiltration of a local anesthetic did not affect infection rates or incisional hernia problems. In regards to limitations, for technical reasons, the intraoperative caregivers were not blinded, unlike the postoperative ones. However, the main focus of the present study was the postoperative analgesia and outcomes. Regarding cardiac and pulmonary complications, the sample size was too small to make any conclusions. To reach reliable results, it was calculated that at least 200 patients would be necessary. However, this was not the focus of this study. This study is a further contribution to the limited experience regarding fast-track abdominal aortic surgery. In this sample of patients, the authors investigated a less invasive alternative to epidural analgesia with good results. It would be interesting to build a large-scale comparative study investigating the hormonal response to stress and the required resources in terms of drugs and surgical, anesthesia, and nursing time. In conclusion, the present results indicated that there was good pain control in both groups, but the epidural anesthesia group required a lower rate of local anesthetic and fewer rescue doses of analgesic drugs. The outcomes of postoperative recovery were similar, allowing for patients to be discharged on day 3 in both groups.
REFERENCES 1. Kehlet H, Wilmore DW: Fast-track surgery. Br J Surg 92:3-4, 2005 2. Carli F, Kehlet H, Baldini G, et al: Evidence basis for regional anaesthesia in multidisciplinary fast-track surgical care pathways. Reg Anesth Pain Med 36:63-72, 2011 3. Brustia P, Renghi A, Fassiola A, et al: Fast-track approach in abdominal aortic surgery: Left subcostal incision with blended anaesthesia. Interact Cardiovasc Thorac Surg 6:60-64, 2007 4. Samama CM: Locoregional anesthesia and agents interfering with haemostasis. Minerva Anestesiol 70:303-305, 2004 5. Kehlet H, Liu SS: Continuous local anesthetic wound infusion to improve postoperative outcome: Back to the periphery? Anesthesiology 107:369-371, 2007
6. Pfeiffer U, Dodson ME, Van Mourik G, et al: Wound instillation for postoperative pain relief: A comparison between bupivacaine and saline in patients undergoing aortic surgery. Ann Vasc Surg 5:80-84, 1991 7. Kehlet H, Wilmore DW: Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg 248:189-198, 2008 8. Kehlet H: Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth 78:606-617, 1997 9. Murphy MA, Richards T, Atkinson C, et al: Fast track open aortic surgery: Reduced postoperative stay with a goal directed pathway. Eur J Vasc Endovasc Surg 34:274-278, 2007 10. Moll FL, Powell JT, Fraedrich G, et al: European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical
458
practice guidelines of the European Society for Vascular Surgery. Eur J Vasc Endovasc Surg 41:S1-S58, 2011 (suppl 1) 11. Moniaci D, Brustia P, Renghi A, et al: Abdominal aortic aneurysm treatment: Minimally invasive fast-track surgery and endovascular technique. Vascular 19:233-241, 2011 12. Chaikof EL, Brewster DC, Dalman RL, et al: The care of patients with an abdominal aortic aneurysm: Society for Vascular Surgery Practice guidelines. J Vasc Surg 50:S2-S49, 2009 (suppl) 13. Kehlet H, Slim K: The future of fast-track surgery. Br J Surg 99:1025-1026, 2012 14. Lassen K, Soop M, Nygren J, et al: Consensus review of optimal perioperative care in colorectal surgery: Enhanced recovery after Surgery (ERAS) Group Recommendations. Arch Surg 144:961-969, 2009 15. Carli F, Kehlet H: Continuous epidural analgesia for colonic surgery-but what about the future. Reg Anesth Pain Med 30:140-142, 2005 16. Kehlet H, Holte K: Effect of postoperative analgesia on surgical outcome. Br J Anaesth 87:62-72, 2001 17. Clemente A, Carli F: The physiological effects of thoracic epidural anesthesia and analgesia on the cardiovascular respiratory and gastrointestinal systems. Minerva Anestesiol 74:549-563, 2008 18. Richman JM, Rowlingson AJ, Maine DN, et al: Does neuraxial anesthesia reduce intraoperative blood loss? A meta-analysis. J Clin Anesth 18:427-435, 2006 19. Kehlet H, Dahl JB: Anaesthesia, surgery, and challenges in postoperative recovery. Lancet 362:1921-1928, 2003 20. Nishimori M, Ballantyne JC, Low JH: Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery. Cochrane Database Syst Rev 3:CD005059, 2006 21. American Society of Anesthesiologists Task Force on Acute Pain Management: Practice guidelines for acute pain management in the perioperative setting: An updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology 100:1573-1581, 2004 22. Carli F, Klubien K: Thoracic epidurals: Is analgesia all we want? Can J Anaesth 46:409-414, 1999 23. Kehlet H: Future perspectives and research initiatives in fasttrack surgery. Langenbecks Arch Surg 391:495-498, 2006 24. Kehlet H: Labat lecture 2005: Surgical stress and postoperative outcome-from here to were? Reg Anesth Pain Med 31:47-52, 2006 25. Liu SS, Richman JM, Thirlby RC, et al: Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: A quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg 203:914-932, 2006 26. Møiniche S, Mikkelsen S, Wetterslev J, et al: A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth 81:377-383, 1998
RENGHI ET AL
27. Fredman B, Zohar E, Tarabykin A, et al: Bupivacaine wound instillation via an electronic patient-controlled analgesia device and a double-catheter system does not decrease postoperative pain or opioid requirements after major abdominal surgery. Anesth Analg 92: 189-193, 2011 28. Schumann R, Shikora S, Weiss JM, et al: A comparison of multimodal perioperative analgesia to epidural pain management after gastric bypass surgery. Anesth Analg 96:469-474, 2003 29. Fustran Guerrero N, Dalmau Llitjós A, Sabaté Pes A: Continuous infusion of local anesthetic at the site of the abdominal surgical wound for postoperative analgesia: A systematic review. Rev Esp Anestesiol Reanim 58:337-344, 2011 30. Beaussier M, El Ayoubi H, Schiffer E, et al: Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: A randomized, doubleblind, placebo-controlled study. Anesthesiology 107:461-468, 2007 31. Brown SL, Morrison AE: Local anesthetic infusion pump systems adverse events reported to the food and drug administration. Anesthesiology 100:1305-1307, 2004 32. Zink W, Graf BM: Local anesthetic myotoxicity. Reg Anesth Pain Med 29:333-340, 2004 33. Kehlet H, Bay-Nielsen M: Local anaesthesia as a risk factor for recurrence after groin hernia repair. Hernia 12:507-509, 2008 34. Brustia P, Porta C: Left subcostal minilaparotomy in aortic surgery. Minerva Cardioangiol 49:91-97, 2001 35. Renghi A, Gramaglia L, Ciarlo M, et al: Fast track in abdominal aortic surgery. Minerva Anestesiol 67:441-446, 2001 36. Brustia P, Renghi A, Gramaglia L, et al: Miniinvasive abdominal aortic surgery. Early recovery and reduced hospitalization after multidisciplinary approach. J Cardiovasc Surg 44:629-635, 2003 37. Shono A, Saito Y, Sakura S, et al: Sevoflurane requirements to suppress responses to transcutaneous electrical stimulation during epidural anesthesia with 0,5% and 1% lidocaine. Anesth Analg 97:11681172, 2003 38. Beattie WS, Badner NH, Choi P: Epidural analgesia reduces postoperative myocardial infarction: A meta-analysis. Anesth Analg 93:853-858, 2001 39. Landesberg G, Shatz V, Akopnik I, et al: Association of cardiac troponin, CK-MB, and postoperative myocardial ischemia with longterm survival after major vascular surgery. J Am Coll Cardiol 42:15471554, 2003 40. Nakamura S, Yoshihara F, Kamide K, et al: Microalbuminuria and deterioration of renal function after elective repair of infrarenal abdominal aortic aneurysm. Clin Nephrol 65:165-172, 2006 41. Pöpping DM, Elia N, Marret E, et al: Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: A meta-analysis. Arch Surg 143:990-999, 2008
doses of anesthetic/analgesic drugs. The postoperative LOC group needed significantly higher doses of bupivacaine (3.9 ⴞ 0.7 mL/h [PERI group] and 5.7 ⴞ 1.3 mL/h [LOC group] on day 0 [p < 0.01]; 3.8 ⴞ 0.8 mL/h [PERI group] and 5.3 ⴞ 1 mL/h [LOC group] on day 1 [p < 0.01]). The parameters of postoperative recovery were comparable between the 2 groups in terms of the resumption of ambulation after surgery (within 3 hours), feeding (within 6 hours), the passage of stools (mean 2 days), and the median hospital stay (3 days). In the 2-year follow-up period, a difference between the 2 groups in the incidence of wound complications was not observed. Conclusions: The results obtained showed good and similar pain control in the 2 groups, but the LOC group required higher doses of anesthetic/analgesic drugs. Parameters of the postoperative recovery were similar in both groups. © 2013 Elsevier Inc. All rights reserved.
F
5 cm or larger in diameter was recommended. Our anesthesiological and surgical team started a program to offer a mini-invasive approach to all patients affected by abdominal aortic aneurysms in an attempt to make this a viable option for patients not eligible for endovascular abdominal aneurysm repair because of unfavorable anatomy, age under 65 years, and aortoiliac occlusive disease. Exclusion criteria included the following: the need for emergency care, the need for retroperitoneal surgical access, and patient refusal. Patients with a history of chronic analgesic drug usage also were excluded from the study. The schedule for randomization was generated randomly using a computer before the initiation of the trial. The allocation of patients was performed with concealed and opaque numbered envelopes. An independent staff member prepared the envelopes. The envelopes were opened by anesthesiologists immediately before surgery. The mini-invasive surgical approach consisted of the following: a left subcostal mini-incision, transperitoneal access without evisceration, and no use of drains or nasogastric tubes. The patient was placed in a dorsal decubitus position to perform midline or transverse laparotomy. The cutaneous incision of 10 to 15 cm, depending on the abdominal size, was parallel to the chondrocostal edge and the spread from the linea alba to the edge of the rectus muscle. The cutaneous incision crossed the linea alba about halfway between the xiphoid and the umbilicus depending on the extension of the aortoiliac aneurysmal disease. The incision of the rectum muscle allowed access to the abdominal cavity. The oblique and transverse muscles were spared. The bowel was maintained within the abdominal cavity. Usually, the self-retaining retractors are not used in order to avoid wall strain and minimize postoperative pain. The abdominal wall and the bowel were retracted gently with moistened towels maintained by the blade of
AST-TRACK SURGERY procedures aim to reduce perioperative stress to improve postoperative recovery.1 A cornerstone of these programs is achieving optimal pain relief.2 With abdominal surgery, including abdominal aortic surgery, there are consistent reports of the efficacy of thoracic epidural anesthesia/analgesia in terms of optimal pain relief and better postoperative outcomes.3 However, this technique requires an increased amount of supervision and is not free from potential risks, primarily the risk of epidural hematoma in patients receiving unfractionated heparin.4 The aim of this study was to investigate a possible alternative to epidural anesthesia/analgesia. Continuous wound infiltration is less invasive although it exposes patients to the risk of surgical wound complications.5,6 The present authors compared thoracic epidural anesthesia/analgesia with continuous wound infiltration anesthesia/analgesia in patients scheduled for miniinvasive abdominal aortic surgery in a fast-track setting. The first endpoint consisted of comparing trends of postoperative pain between the 2 groups. Moreover, the main determinants of the postoperative outcome and the incidence of complications in the immediate postoperative period and in the 2-year follow-up period were compared. This prospective randomized study was conducted to test the hypothesis that thoracic epidural analgesia provides better postoperative pain control and a quicker recovery in the postoperative period compared with continuous wound infiltration with a local anesthetic. METHODS A prospective randomized study was conducted on 60 consecutive patients scheduled for elective mini-invasive abdominal aortic surgery in a fast-track setting. The patients were enrolled at the Vascular Surgery Department, University Hospital “Maggiore della Carità,” Novara, Italy, between February 1, 2005, and February 1, 2006. The study was designed according to the Declaration of Helsinki principles. The study project was submitted to and approved by the Inter-Hospital Ethics Committee of Novara. Each patient signed a written consent form before participation in the study. Elective aneurysm repair for patients with an infrarenal abdominal aortic aneurysm
KEY WORDS: blended anesthesia, fast-track aortic surgery, postoperative outcome, local anesthesia, epidural anesthesia
From the Departments of *Anaesthesia and †Vascular Surgery, University Hospital “Maggiore della Carità,” Novara, Italy. Address reprint requests to Alessandra Renghi, MD, University Hospital “Maggiore della Carità,” Corso Mazzini, 18, 28100 Novara, Italy. E-mail: [email protected] © 2013 Elsevier Inc. All rights reserved. 1053-0770/2703-0001$36.00/0 http://dx.doi.org/10.1053/j.jvca.2012.09.026
Journal of Cardiothoracic and Vascular Anesthesia, Vol 27, No 3 (June), 2013: pp 451-458
451
452
RENGHI ET AL
intestinal retractors. The next surgical steps were performed according to traditional methods. At the end of the surgery, the patients were transferred directly to the surgical ward where the accelerated rehabilitation protocol started immediately based on early feeding and ambulation. All patients underwent blended anesthesia, which included general and peripheral anesthesia. Based on the results from the randomization, the patients were assigned to 2 different groups: the epidural thoracic anesthesia/ analgesia group (the PERI group) and the continuous wound infiltration anesthesia/analgesia group (the LOC group). Two hours before surgery, all the patients were transferred to the holding area near the operating room where they were monitored with continuous electrocardiography, oximetry, and invasive measure of arterial pressure (the radial catheter was removed at the end of surgery). Preoperatively, both groups received intravenous administration of proparacetamol (2 g), metoclopramide (10 mg), fentanyl (100 g), droperidol (2.5 mg), and midazolam (0.02 mg/kg). In both groups, general anesthesia consisted of the following: intravenous administration of titrated propofol (0.5-1.5 mg/kg) and cisatracurium (0.2 mg/kg), placement of a laryngeal mask, mechanical ventilation (tidal volume of 9 mL/kg), maintenance with sevoflurane at a concentration of 0.6% to 1% minimum alveolar concentration, and administration of intravenous ephedrine (10 mg) if the mean blood pressure was lower than 60 mmHg. All the patients received unfractionated heparin at a dose of 50 IU/kg so the activated coagulation time was higher than 200 seconds. During the preoperative period in the PERI group, an epidural catheter was placed at the T6-T7 level, and the patient was given subsequent doses of 2 to 4 mL of levobupivacaine (0.5%) until dermatomeric extension was achieved using the ice test (evaluation of thermal sensibility using ice cubes) equal to T3-S2 (for a maximum total of 25
Enrollment
mL). At the end of surgery, an epidural infusion of levobupivacaine, 0.25% at 4 mL/h, was started for postoperative analgesia. During the preoperative period in the LOC group, the fascia of the parietal peritoneum was infiltrated subcutaneously with 20 mL of levobupivacaine (0.5%). At the end of surgery, subfascial and subcutaneous placement of a double multiperforated catheter was performed, and an infusion of levobupivacaine, 0.25% at 4 mL/h, was started for postoperative analgesia. In the postoperative period, data were collected by doctors and nurses blinded to the analgesic regimen used. To ensure that all personnel were blinded, all patients had identical infusion pumps visible at the shoulder level. Postoperative analgesia was provided with a 48-hour infusion (either an epidural or wound infiltration) of levobupivacaine (0.25% at 4 mL/h). Nurses could make changes within the 2- to 8-mL/h range according to the following criteria: the visual analog scale (VAS) score, which quantifies pain intensity from 0 to 100; mobility recovery; and the patients’ hemodynamic parameters. The maximum dose of levobupivacaine was 400 mg per 24 hours. All patients received oral ibuprofen (600 mg) every 8 hours, and a rescue intravenous dose of ketorolac (30 mg) was available when the VAS was higher than 50. The patients were discharged to home, and the outpatient visits were scheduled 3 and 7 days later. In the follow-up period, the patients were evaluated 3, 6, 12, and 24 months after discharge. The primary outcome measures were related to pain control quality and the parameters of postoperative recovery and included the following: the VAS score at rest and during walking, the dose rate of the epidural or local infusion, the use of supplemental anesthetics or analgesic drugs, the resumption of oral feeding, the resumption of ambulation, and the day of discharge. The secondary outcome measures were related to the hemodynamic perioperative rebound of the
Assessed for eligibility (n=60)
Excluded (n=1) Not meeting inclusion criteria (n=0) Declined to participate (n=0) Other reasons (n=1) Randomized (n=59)
Allocation Allocated to intervention with peridural (n=29) Received allocated intervention (n=29) Did not receive allocated intervention (n=0)
Allocated to intervention with local (n=30) Received allocated intervention (n=30) Did not receive allocated intervention (n=0)
Follow-Up Lost to follow-up (n=0)
Lost to follow-up (n=0)
Discontinued intervention (n=0)
Discontinued intervention (n=0)
Analysis Analysed (n=29) Excluded from analysis (n=0)
Analysed (n=30) Excluded from analysis (n=0)
Fig 1. A diagrammatic representation of the patient distribution.
FAST-TRACK ABDOMINAL AORTIC SURGERY
453
Table 1. Demographic Characteristics and Intraoperative Parameters Intraoperative Period
Women, n (%) Men, n (%) Age, y (mean ⫾ SD) Body mass index (mean ⫾ SD) ASA class 2, n (%) 3, n (%) 4, n (%) Operation length, min (mean ⫾ SD) Clamping length, min (mean ⫾ SD) Hemorrhage, mL (mean ⫾ SD) Diuresis, mL/h (mean ⫾ SD) Total infusions,* mL (mean ⫾ SD) Colloids, mL (mean ⫾ SD) Crystalloids, mL (mean ⫾ SD) Cell saver recovered and transfused blood, mL (mean ⫾ SD) Ephedrine, mg (mean ⫾ SD)
PERI Group (29 Patients)
LOC Group (30 Patients)
3 (10.3) 26 (89.7) 72.2 ⫾ 9.6 25.7 (⫾ 3.6)
2 (6.7) 28 (93.3) 68.9 ⫾ 10 25.2 (⫾ 2.9)
3 (10.3) 15 (51.7) 11 (37.9) 151.7 ⫾ 43.7 71.6 ⫾ 26.1 806.9 ⫾ 655.2 197.5 ⫾ 108.9 2436.4 ⫾ 683.3 613.8 ⫾ 245.3 1548.3 ⫾ 358.7 230.7 ⫾ 248.8 38 ⫾ 27.5
4 (13.3) 23 (76.7) 3 (10) 164.9 ⫾ 53.3 74.1 ⫾ 37.4 736.7 ⫾ 298.8 192.7 ⫾ 104 2354.3 ⫾ 580.4 526.7 ⫾ 170.6 1576.7 ⫾ 389.4 268.7 ⫾ 237.8 18.9 ⫾ 15.3
p Value
0.97 0.21 0.6 0.04
0.31 0.77 0.6 0.86 0.62 0.12 0.77 0.55 0.002
Abbreviations: PERI, thoracic epidural infusion; LOC, continuous local wound infiltration; SD, standard deviation; ASA, American Society of Anesthesiologists. *Colloids ⫹ crystalloids ⫹ cell saver recovered and transfused blood ⫹ autologous transfused blood.
analgesic regimen and postoperative complications. In particular, postoperative complications related to analgesia in the immediate (ie, 30 days) and long-term periods (ie, 2 years) were evaluated. The sample was evaluated using an ␣ error of 0.05 and a power of 80%. The authors assumed an expected difference between the groups of 20 for the VAS (necessary sample equal to 17 patients), 2 hours for the expected return to ambulation (necessary sample equal to 26 patients), 4 hours until the first food intake (necessary sample equal to 6 patients), and 1 day for the time to discharge (necessary sample equal to 17 patients). The randomization, which was created by a computer, was contained in opaque envelopes that were opened upon the patients’ arrival in the operating room. The data were analyzed using Epi Info (Centers for Disease Control and Prevention, Atlanta, Georgia). The nominal variables were described as relative and absolute frequencies, and the differences between the 2 groups were evaluated with the chi-square test. Nonparametric data were expressed as medians with ranges. The variables considered continuous and normally distributed were described as means ⫾ 1 standard deviation. Statistical analysis was conducted using the 2-sided Student t test for normally distributed independent variables. A p value ⬍0.05 was considered significant. RESULTS
Between February 1, 2005, and February 1, 2006, 59 patients were studied. Twenty-nine patients were assigned to the PERI
Fig 2. The intraoperative cardiocirculatory parameters. MBP, mean blood pressure; Hr, heart rate; bas, basal at the arrival in the operating room; induct, after anesthesia induction; preclamp, 5 minutes before abdominal aortic clamping; postclamp, 5 minutes after abdominal aortic clamping; declamp, 5 minutes after abdominal aortic declamping; end, after the patient was awake; p** refers to the difference in the MBP between the PERI group and the LOC group.
group (1 patient was excluded because of the intraoperative detection of pancreatic neoplasia not visualized after the preoperative computed tomography scan), and 30 patients were assigned to the LOC group (Fig 1). The demographic characteristics and intraoperative data are provided in Table 1. The intraoperative use of inotropic drugs was necessary for 3 patients in the PERI group and 2 patients in the LOC group, whereas the use of vasodilators was necessary for 1 patient in the PERI group and 4 patients in the LOC group. Intraoperatively, 1 patient in each group received concentrated erythrocytes. The intraoperative cardiocirculatory parameters are expressed in Figure 2. The minimum alveolar concentration of sevoflurane used during surgery is shown in Figure 3. The intraoperative use of remifentanil was necessary in 4 patients in the PERI group and 27 patients in the LOC group. Figure 4 shows the lower mean blood pressure postoperatively in the PERI group compared with the LOC group; the heart rate was similar in both groups. The removal of the laryngeal mask in the operating room was successful in all cases, and all the patients were transferred to the surgical ward. No patients were admitted to the intensive care unit. In the 48-hour postoperative period, 3 patients in the
454
RENGHI ET AL
Fig 3. The minimum alveolar concentration of sevoflurane.
LOC group experienced hypertensive episodes. No patients in the PERI group experienced postoperative hypertension. The PERI group had a lower (although not significant) VAS score than the LOC group both at rest and when walking, especially on the day of the surgery (Fig 5). The data were confirmed by changes (Table 2) in the rate of the local anesthetic infused (compared with the basal infusion of 4 mL/h) on the day of surgery (day 0) and on the day after surgery (day 1). Despite the greater use of local anesthetics, the patients in the LOC group asked for more analgesic rescue doses of ketorolac (30 mg). In the 24 hours after surgery, 6 patients in the PERI group and 15 patients in the LOC group requested a rescue dose. A rescue dose of subcutaneous morphine (0.1/mg kg) was necessary in 1 patient in the LOC group because the VAS score remained higher than 50 at rest and was equal to 80 when in motion. The primary parameters of postoperative complications in the 2 patient groups are shown in Table 3. No clinically evident pulmonary complications were found throughout the study. Chest radiographic examinations performed on the 2nd day
Fig 4. The postoperative hemodynamic parameters. MBP, mean blood pressure; Hr, heart rate; p** refers to the difference in the MBP in the PERI group versus the MBP in the LOC group. ***Arrival in the surgical ward.
after surgery revealed signs of impaired ventilation at the left pulmonary base (ie, the seat of the surgical mini-incision) in 10 patients in the PERI group and 10 patients in the LOC group. The primary parameters of postoperative recovery in the 2 patient groups are shown in Table 4. On day 0, 6 patients in the PERI group and 3 patients in the LOC group had vomiting episodes. In both cases, it was necessary to give liquid oral medications via an alternate delivery route. In the PERI group, only 1 patient refused dinner compared with 4 patients in the LOC group. All patients ate their meals the following day. No significant differences were observed with regard to the time to the first standing in the 2 groups. The mean VAS score in the PERI group varied from 20 at rest to 30 in motion, whereas in the LOC group the VAS score ranged from 32 at rest to 39 in motion. In both groups, the VAS scores at rest and in motion always were less than 40. The mean blood pressure before the time to the first standing was 80.8 ⫾ 20.4 mmHg in patients in the PERI group and 85.6 ⫾ 11.8 mmHg in the LOC patient group. The mean blood pressure
FAST-TRACK ABDOMINAL AORTIC SURGERY
455
Fig 5. The postoperative VAS. *Arrival in the surgical ward.
after the first standing was 77.1 ⫾ 21.4 mmHg in the PERI group and 82.4 ⫾ 15.9 mmHg in the LOC group. Two years after surgery, all patients were alive and strictly adherent to the follow-up. During this period, 1 patient in each group presented with wound serosity, and 1 patient in the PERI group developed a bulging wound (loosening in the lateral seat of the rectus abdominal muscle). DISCUSSION
Fast-track surgery is a multidisciplinary approach aimed at minimizing perioperative stress determinants to reduce postoperative complications and the time of recovery until “daily normal activities” can be resumed.1 Evidence in fast-track surgery suggests that it is associated with a reduction of costs and the risk of medical complications.7 Since the early 1990s, minimally invasive surgical approaches have been investigated heavily in addition to anesthesiology stress-free techniques and postoperative fast rehabilitation programs.1,2,8 Abdominal aortic surgery is also a realm in which the fast-track approach can improve outcomes, reduce postoperative complications, and reduce the length of hospital stay.3,9-11 However, fast-track abdominal aortic surgery remains the practice of a few specialized centers even if the benefits are well recognized.12 The major components of fast-track methodology are miniinvasive surgery, regional anesthesia and analgesia techniques,
Table 2. Local Anesthetic Infusion Rates on Days 0 and 1
Day 0: infusion of local anesthetic, mL/h (mean ⫾ SD) Day 1: infusion of local anesthetic, mL/h (mean ⫾ SD) Day 0: changes in local anesthetic infusion rates Increase Decrease Day 1: changes in local anesthetic infusion rates Increase Decrease
PERI Group (29 patients)
LOC Group (30 patients)
p Value
3.9 ⫾ 0.7
5.7 ⫾ 1.3
⬍.01
3.8 ⫾ 0.8
5.3 ⫾ 1
⬍.01
3 patients 4 patients
21 patients 2 patients
1 patient 5 patients
3 patients 11 patients
Abbreviations: PERI, thoracic epidural infusion, LOC, continuous local wound infiltration; SD, standard deviation.
and postoperative rehabilitation programs (early feeding and ambulation).2,13 In 2012, Khelet and Slim13 affirmed that regional anesthesia should be used whenever possible. Most fast-track experiences involve the use of thoracic epidural anesthesia and analgesia.2,14,15 Thoracic epidural anesthesia has been used widely to provide excellent pain relief. Thoracic epidural anesthesia attenuates the catabolic response to abdominal surgery; lowers the incidence of pulmonary morbidity; decreases the cardiac metabolic demand; reduces the risk of thromboembolic complications; promotes the recovery of intestinal function; and minimizes motor blockade, thus facilitating early mobilization.2,15-17 In addition, neuroaxial anesthesia reduces intraoperative blood loss.18 Despite these beneficial physiologic effects, the outcome trials still provided uncertain results, probably because the overall perioperative care was not adjusted.15,19 A Cochrane review in aortic surgery concluded that epidural analgesia provides better pain relief and reduces postoperative complications but does not have beneficial effects on postoperative mortality.20 Carli et al2 affirmed that although it might still be difficult to determine how a sole intervention such as regional anesthesia might have an impact on outcome, thoracic epidural anesthesia remains the only regional technique reasonably used in patients undergoing open abdominal fast-track surgery. Unfortunately, this technique requires a large amount of supervision, especially to avoid hypotension and impairment of the lower limbs.21 Watchful monitoring in the postoperative period is essential; pain relief must be tailored to the requirement of each individual patient by monitoring the sensory and motor blockade and the side effects (eg, sedation, hypotension, and early signs of spinal hematoma).22,23 The effective and safe management of epidural analgesia requires that patients are observed systematically by a competent staff.19 Furthermore, in patients on antiplatelet therapy and candidates for systemic intraoperative heparinization, the procedure is not risk free, and some authors advise against its use.4 Since 2006, Kehlet23,24 has invited anesthesiologists to search for analgesic techniques that are as effective as epidural analgesia but less invasive. He himself has evaluated the efficacy of wound infiltration with local anesthetics.5 Wound infiltration with a local anesthetic is a relatively simple technique that provides analgesia by both directly blocking the painful transmission and by inhibiting the local inflammatory response.25 Its efficacy in analgesic terms is controversial in the
456
RENGHI ET AL
Table 3. Postoperative Complications PERI Group
Postoperative complications related to analgesia Day 0
Day 1 Increased troponin levels† Day 0 Day 2
LOC Group
1 hypotension
1 lipothymia* 1 lower limb hyposthenia
1 1 1 1 2 2
hypotension lypothymia lower-limb hyposthenia hypertension lypothymia hypertension
None 5 patients (consistently lower 0.5 ng/mL)
1 patient (0.94 ng/mL) 3 patients: 2 patients had values higher than 1 ng/mL, 1 of whom reached a value of 26 ng/mL‡
1 patient had sinus tachycardia 1 patient had suspected left ventricle overload
1 1 1 1
5 patients
7 patients
152.9 ⫾ 190.4 mg/d
249.4 ⫾ 665 mg/d
Electrocardiographic changes† patient had sinus tachycardia patient had suspected left ventricle overload patient had a small Q wave in D3 patient had a type 1 atrioventricular block with a left bundlebranch block isolated extrasistoles (patient’s troponin level on day 2 was 0.16 ng/mL) 1 patients had sinus tachycardia and signs of previous lower necrosis (the patient’s day 2 troponin level was 26 ng/mL)
Temporary creatinine increases§ Microalbuminuria during the 24 h after surgery (p ⫽ 0.48) Abbreviations: PERI, thoracic epidural infusion; LOC, continuous local wound infiltration. *Transient postural collapse without a loss of consciousness. †Cardiac events were monitored daily with troponin measurements and a 12-lead electrocardiographic record. ‡This patient was successfully treated with specific medical therapy. §Temporary creatinine increases: more than 50% compared with the basal value, which normalized by 4th postoperative day.
literature, especially in major abdominal surgery.2 In a review involving 1,211 patients, Møiniche et al26 concluded that after abdominal surgery there was a lack of evidence regarding the effect of incisional local anesthesia on postoperative pain except for herniotomy. Liu et al25 conducted a meta-analysis including 2,141 patients to determine the efficacy of the continuous infusion of local anesthetic into wounds at the end of surgery and showed that this modality considerably decreased the pain score and the need for opioids. However, the most notable results were in the orthopedic group, and, conversely, in general surgery (including upper abdominal and vascular surgery) the benefits were less evident. In 2001, 50 patients
undergoing major abdominal surgery were enrolled in a prospective study by Fredman et al27 who concluded that bupivacaine wound instillation does not decrease postoperative pain. In a comparative study involving 114 patients undergoing gastric bypass surgery under general anesthesia, Schumann et al28 concluded that infiltration analgesia offers a simple, safe, and inexpensive alternative to epidural pain control. In a recent systematic review, Fustran Guerrero et al29 observed that surgical wound analgesia is effective only in cesarean sections and hysterectomies, and, conversely, the outcomes for other types of surgery are inconsistent. Beaussier et al30 proposed that the continuous preperitoneal administration of ropivacaine after
Table 4. Primary Postoperative Recovery Parameters Parameters
PERI Group (29 Patients)
LOC Group (30 Patients)
p Value
First intake of liquids (hours from the end of surgery) First intake of solids (hours from the end of surgery) First time to stand (hours from the end of surgery) Hours of ambulation when first standing Meters of ambulation when first standing Passage of stool (hours from the end of surgery) Changes in the levels of blood glucose (mg/dL) on day 0 Changes in the levels of blood glucose (mg/dL) on day 1 Mean time to discharge (d)
1.768 ⫾ 1.26 3.5 ⫾ 3 2.37 ⫾ 0.935 0.085 ⫾ 0.036 45.8 ⫾ 21.6 46.7 ⫾ 20.1 137.86 ⫾ 30.76 122.86 ⫾ 26.16 3.2 ⫾ 1.4
1.24 ⫾ 0.475 5.64 ⫾ 6.3 2.596 ⫾ 2.598 0.073 ⫾ 0.028 38.2 ⫾ 18.2 50.7 ⫾ 30.2 144.1 ⫾ 39.88 126.27 ⫾ 25.53 3.4 ⫾ 1.7
0.04 0.11 0.67 0.15 0.16 0.56 0.51 0.63 0.76
Abbreviations: PERI, thoracic epidural infusion; LOC, continuous local wound infiltration.
FAST-TRACK ABDOMINAL AORTIC SURGERY
457
colorectal resection reduced morphine consumption, improved pain relief, and accelerated postoperative recovery despite the fact that a control group of epidural anesthesia was not provided. Only one study involving abdominal aortic surgery did not show that wound instillation with bupivacaine improves pulmonary function or reduces morphine requirements.31 All the experiences did not report side effects (ie, no wound infection or systemic toxicity). Moreover, although it is a simple technique, it presents the following potential risks: the need for high dosages can cause local anesthetic toxicity problems, there is a risk of myotoxicity and myonecrosis, and the Food and Drug Administration emphasizes the risk of local injury in terms of wound infection and necrosis.5,6,27,32 Kehlet and Bay-Nielsen33 assessed 43,123 patients undergoing groin hernia repair and concluded that local anesthesia may be a risk factor for recurrence. Since 2000, the present authors studied fast-track programs in abdominal aortic surgery comprising left subcostal minilaparotomy, thoracic epidural anesthesia/analgesia, and enforced postoperative rehabilitation.34-36 They compared local anesthesia/analgesia with wound infiltration versus thoracic epidural anesthesia for abdominal aortic surgery. The authors sought to verify whether less invasive anesthesia/analgesia compared with thoracic epidural anesthesia/analgesia allows for the maintenance of excellent analgesia and positively impacts the postoperative outcome in terms of reducing complications and accelerating recovery. In the present authors’ experience, the analgesic efficacy of epidural and local anesthesia were comparable. Good VAS values (on a scale from 0 to 100) were observed in both groups. The VAS values were always below 40, except for the VAS values with movement in the LOC group when arriving back from the operating room (VAS ⫽ 44). In the intraoperative period, lower quantities of sevoflurane and remifentanil were used in the PERI group, confirming that epidural analgesia decreases the general anesthetic requirements.37 In the postoperative period, especially in the first 24 hours, significantly higher doses of local anesthetics were necessary in the LOC group. Moreover, the PERI group patients required lower analgesic rescue doses. During the entire perioperative period, a lower mean blood pressure was observed in the PERI group compared with the LOC group, which did not cause an increase in heart rate in the PERI group. Likewise, lower blood pressure values in the PERI group did not influence the time and outcomes related to the time to the first standing.
In the LOC group, a significant increase in troponin values and a greater number of electrocardiographic changes were observed. In fact, epidural anesthesia could have contributed to the reduction of ischemic risks in the perioperative period, as suggested by several previous studies.38 This is notable because troponin increases provide a possible long-term mortality index in vascular patients.39 In the PERI group, lower values of microalbuminuria were observed in the postoperative period. Even if the data are not significant, the data are important to note because microalbuminuria is associated with a decreased prognosis for short- and long-term kidney function after abdominal aortic surgery.40 The present authors did not find any pulmonary complications confirming the use of epidural analgesia in reducing postoperative pulmonary morbidity.41 The parameters of the postoperative recovery were similar in the 2 groups in terms of the resumption of ambulation (within 3 hours after surgery) and feeding (within 2 hours after surgery for liquids and within 6 hours for solid foods), the passage of stools (2nd postoperative day), and the median hospital stay (3 days). At the 2-year follow-up, a difference in wound complication rates was not observed. In the present authors’ experience, the infiltration of a local anesthetic did not affect infection rates or incisional hernia problems. In regards to limitations, for technical reasons, the intraoperative caregivers were not blinded, unlike the postoperative ones. However, the main focus of the present study was the postoperative analgesia and outcomes. Regarding cardiac and pulmonary complications, the sample size was too small to make any conclusions. To reach reliable results, it was calculated that at least 200 patients would be necessary. However, this was not the focus of this study. This study is a further contribution to the limited experience regarding fast-track abdominal aortic surgery. In this sample of patients, the authors investigated a less invasive alternative to epidural analgesia with good results. It would be interesting to build a large-scale comparative study investigating the hormonal response to stress and the required resources in terms of drugs and surgical, anesthesia, and nursing time. In conclusion, the present results indicated that there was good pain control in both groups, but the epidural anesthesia group required a lower rate of local anesthetic and fewer rescue doses of analgesic drugs. The outcomes of postoperative recovery were similar, allowing for patients to be discharged on day 3 in both groups.
REFERENCES 1. Kehlet H, Wilmore DW: Fast-track surgery. Br J Surg 92:3-4, 2005 2. Carli F, Kehlet H, Baldini G, et al: Evidence basis for regional anaesthesia in multidisciplinary fast-track surgical care pathways. Reg Anesth Pain Med 36:63-72, 2011 3. Brustia P, Renghi A, Fassiola A, et al: Fast-track approach in abdominal aortic surgery: Left subcostal incision with blended anaesthesia. Interact Cardiovasc Thorac Surg 6:60-64, 2007 4. Samama CM: Locoregional anesthesia and agents interfering with haemostasis. Minerva Anestesiol 70:303-305, 2004 5. Kehlet H, Liu SS: Continuous local anesthetic wound infusion to improve postoperative outcome: Back to the periphery? Anesthesiology 107:369-371, 2007
6. Pfeiffer U, Dodson ME, Van Mourik G, et al: Wound instillation for postoperative pain relief: A comparison between bupivacaine and saline in patients undergoing aortic surgery. Ann Vasc Surg 5:80-84, 1991 7. Kehlet H, Wilmore DW: Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg 248:189-198, 2008 8. Kehlet H: Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth 78:606-617, 1997 9. Murphy MA, Richards T, Atkinson C, et al: Fast track open aortic surgery: Reduced postoperative stay with a goal directed pathway. Eur J Vasc Endovasc Surg 34:274-278, 2007 10. Moll FL, Powell JT, Fraedrich G, et al: European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical
458
practice guidelines of the European Society for Vascular Surgery. Eur J Vasc Endovasc Surg 41:S1-S58, 2011 (suppl 1) 11. Moniaci D, Brustia P, Renghi A, et al: Abdominal aortic aneurysm treatment: Minimally invasive fast-track surgery and endovascular technique. Vascular 19:233-241, 2011 12. Chaikof EL, Brewster DC, Dalman RL, et al: The care of patients with an abdominal aortic aneurysm: Society for Vascular Surgery Practice guidelines. J Vasc Surg 50:S2-S49, 2009 (suppl) 13. Kehlet H, Slim K: The future of fast-track surgery. Br J Surg 99:1025-1026, 2012 14. Lassen K, Soop M, Nygren J, et al: Consensus review of optimal perioperative care in colorectal surgery: Enhanced recovery after Surgery (ERAS) Group Recommendations. Arch Surg 144:961-969, 2009 15. Carli F, Kehlet H: Continuous epidural analgesia for colonic surgery-but what about the future. Reg Anesth Pain Med 30:140-142, 2005 16. Kehlet H, Holte K: Effect of postoperative analgesia on surgical outcome. Br J Anaesth 87:62-72, 2001 17. Clemente A, Carli F: The physiological effects of thoracic epidural anesthesia and analgesia on the cardiovascular respiratory and gastrointestinal systems. Minerva Anestesiol 74:549-563, 2008 18. Richman JM, Rowlingson AJ, Maine DN, et al: Does neuraxial anesthesia reduce intraoperative blood loss? A meta-analysis. J Clin Anesth 18:427-435, 2006 19. Kehlet H, Dahl JB: Anaesthesia, surgery, and challenges in postoperative recovery. Lancet 362:1921-1928, 2003 20. Nishimori M, Ballantyne JC, Low JH: Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery. Cochrane Database Syst Rev 3:CD005059, 2006 21. American Society of Anesthesiologists Task Force on Acute Pain Management: Practice guidelines for acute pain management in the perioperative setting: An updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology 100:1573-1581, 2004 22. Carli F, Klubien K: Thoracic epidurals: Is analgesia all we want? Can J Anaesth 46:409-414, 1999 23. Kehlet H: Future perspectives and research initiatives in fasttrack surgery. Langenbecks Arch Surg 391:495-498, 2006 24. Kehlet H: Labat lecture 2005: Surgical stress and postoperative outcome-from here to were? Reg Anesth Pain Med 31:47-52, 2006 25. Liu SS, Richman JM, Thirlby RC, et al: Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: A quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg 203:914-932, 2006 26. Møiniche S, Mikkelsen S, Wetterslev J, et al: A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth 81:377-383, 1998
RENGHI ET AL
27. Fredman B, Zohar E, Tarabykin A, et al: Bupivacaine wound instillation via an electronic patient-controlled analgesia device and a double-catheter system does not decrease postoperative pain or opioid requirements after major abdominal surgery. Anesth Analg 92: 189-193, 2011 28. Schumann R, Shikora S, Weiss JM, et al: A comparison of multimodal perioperative analgesia to epidural pain management after gastric bypass surgery. Anesth Analg 96:469-474, 2003 29. Fustran Guerrero N, Dalmau Llitjós A, Sabaté Pes A: Continuous infusion of local anesthetic at the site of the abdominal surgical wound for postoperative analgesia: A systematic review. Rev Esp Anestesiol Reanim 58:337-344, 2011 30. Beaussier M, El Ayoubi H, Schiffer E, et al: Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: A randomized, doubleblind, placebo-controlled study. Anesthesiology 107:461-468, 2007 31. Brown SL, Morrison AE: Local anesthetic infusion pump systems adverse events reported to the food and drug administration. Anesthesiology 100:1305-1307, 2004 32. Zink W, Graf BM: Local anesthetic myotoxicity. Reg Anesth Pain Med 29:333-340, 2004 33. Kehlet H, Bay-Nielsen M: Local anaesthesia as a risk factor for recurrence after groin hernia repair. Hernia 12:507-509, 2008 34. Brustia P, Porta C: Left subcostal minilaparotomy in aortic surgery. Minerva Cardioangiol 49:91-97, 2001 35. Renghi A, Gramaglia L, Ciarlo M, et al: Fast track in abdominal aortic surgery. Minerva Anestesiol 67:441-446, 2001 36. Brustia P, Renghi A, Gramaglia L, et al: Miniinvasive abdominal aortic surgery. Early recovery and reduced hospitalization after multidisciplinary approach. J Cardiovasc Surg 44:629-635, 2003 37. Shono A, Saito Y, Sakura S, et al: Sevoflurane requirements to suppress responses to transcutaneous electrical stimulation during epidural anesthesia with 0,5% and 1% lidocaine. Anesth Analg 97:11681172, 2003 38. Beattie WS, Badner NH, Choi P: Epidural analgesia reduces postoperative myocardial infarction: A meta-analysis. Anesth Analg 93:853-858, 2001 39. Landesberg G, Shatz V, Akopnik I, et al: Association of cardiac troponin, CK-MB, and postoperative myocardial ischemia with longterm survival after major vascular surgery. J Am Coll Cardiol 42:15471554, 2003 40. Nakamura S, Yoshihara F, Kamide K, et al: Microalbuminuria and deterioration of renal function after elective repair of infrarenal abdominal aortic aneurysm. Clin Nephrol 65:165-172, 2006 41. Pöpping DM, Elia N, Marret E, et al: Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: A meta-analysis. Arch Surg 143:990-999, 2008