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Effect of trochar site lidocaine on postoperative pain scoring and patient satisfaction after gynecologic laparoscopies – A randomized clinical trial
Middle East Fertility Society Journal (2011) 16, 131–136
Middle East Fertility Society
Middle East Fertility Society Journal www.mefsjournal.com www.sciencedirect.com
ORIGINAL ARTICLE
Effect of trochar site lidocaine on postoperative pain scoring and patient satisfaction after gynecologic laparoscopies – A randomized clinical trial Kamal M. Zahran a b c
a,*
, Ayman M. Osman b, Jelan A. Abd Elaleem
c
Department of Obstetrics and Gynecology, Women’s Health Centre, Assiut University, Egypt Department of Anesthesia and Intensive Care, Assiut University, Egypt Department of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Egypt
Received 5 October 2010; accepted 10 December 2010 Available online 22 January 2011
KEYWORDS Trochar site lidocaine; Postoperative pain; Gynecologic laparoscopies
Abstract Objective: To assess the effectiveness of lidocaine infiltrated at trochar sites on postoperative pain scoring and patient satisfaction after gynecological laparoscopies. Methods: 160 infertile women scheduled for laparoscopy were randomized to have intraperitoneal lidocaine alone or intraperitoneal lidocaine combined with lidocaine infiltrated at trochar sites. Visual analog score (VAS) was used for assessment of pain severity at trochar sites, shoulder and global abdomen regions on the 1st and 7th postoperative days and verbal analog scoring was used to asses patient satisfaction. Results: Women who received intraperitoneal lidocaine alone showed significantly higher VAS scores at trochar site (3.2 ± 1.8 vs. 1.8 ± 1.6) and global abdominal region (3.4 ± 1.7 vs. 2.6 ± 1.6) on the 1st postoperative day. Shoulder pain scores did not show significant difference between the two groups. Patients who received intraperitoneal lidocaine combined with lidocaine infiltrated at the trochar sites reported higher satisfaction score with the overall postoperative care in the first 24 h.
* Corresponding author. Tel.: +20 882 41 4616, mobile: +20 127432270, priv.: +20 889203555; fax: +20 882 368377. E-mail address: [email protected] (K.M. Zahran). 1110-5690 Ó 2011 Middle East Fertility Society. Production and hosting by Elsevier B.V. All rights reserved. Peer review under responsibility of Middle East Fertility Society. doi:10.1016/j.mefs.2010.12.004
Production and hosting by Elsevier
132
K.M. Zahran et al. Conclusion: The combined use trochar sites and intraperitoneal lidocaine is superior to intraperitoneal lidocaine alone in managing postoperative pain after laparoscopic gynecological procedures. It leads to lower VAS at day 1 and day 7 postoperatively, less need for additional analgesics and higher patient satisfaction. Ó 2011 Middle East Fertility Society. Production and hosting by Elsevier B.V. All rights reserved.
1. Introduction Postoperative pain is less intense after laparoscopic than open surgery. However, minimally invasive surgery is not a pain-free procedure (1). The cause of postoperative pain after laparoscopic surgeries is multifactorial, visceral pain and residual pneumoperitoneum are major contributors (2–4). The intraperitoneal (IP) administration of local anesthetic (LA) during gynecologic laparoscopies results in improved initial pain relief and opioid dose sparing (5). However, a systematic review of IP bupivacaine administration for laparoscopic cholecystectomy found nine negative and 15 positive trials for significant analgesic benefit and concluded that, because of the low study quality and conflicting results, the use of IP LA could not be recommended (6). Another systematic review found IP LA significantly reduced pain scores at 4 h (7). Blocking peritoneal afferents via Instillation of local anesthetics intraperitoneally is claimed to have beneficial effect after gynecologic laparoscopic surgeries (8,9). Local anesthetic infiltration of the incision sites decreases postoperative opiate requirement and improves subjective pain scores but does not entirely eliminate the pain (10). Combination of local infiltration and intraperitoneal instillation of ropivacaine is more effective for pain relief in children after laparoscopic surgery than the administration of ropivacaine only at the trochar sites (1). Five of six studies in which LA were injected locally found beneficial effects on postoperative pain but not analgesic consumption for up to 24 h postoperatively. When injected intraperitoneally, 14 of 23 studies found a reduction in pain scores in the LA group but only 9 of 21 found a reduction in analgesic consumption (11). Twenty percent of chronic pain patients implicate surgery as one of the causes of their chronic pain and, in about half of them; it was the sole cause (12). Recalling of severe acute postoperative pain was among the risk factors for development of chronic pain (13). Recent reports showed the overall incidence of chronic postcesarean pain to vary between 12.3% (14) and 17.8% (15). Strategies to reduce chronic postsurgical pain include utilizing minimally invasive surgical techniques to avoid nerve damage and using local anesthetics (16). Postoperative pain after laparoscopic surgery is less than after laparotomy, and patients may benefit from peripheral use of local anesthetic as in case of minor open procedures. Peripheral use of local anesthetic may include both intraperitoneal instillation and port site infiltration (3). We aimed to assess the effectiveness and safety of lidocaine infiltrated at the trochar site on postoperative pain scoring, patient satisfaction and incidence of chronic pain development after gynecologic laparoscopies. In the current work lidocaine was used via both its infiltration at the port wound site and its intraperitoneal instillation for the management of post operative pain after gynecological laparoscopies. We hypothesize that port site infiltration and intraperitoneal instillation of
lidocaine will block both somatic and visceral pain elements, respectively. Patients in the current study were also observed for the incidence of chronic pain development after such a minor procedure. 2. Materials and methods 2.1. Eligibility and randomization This randomized double-blind placebo-controlled clinical study took place at the Women’s Health Centre, Assiut University, from November 2008 through April 2010. The study was approved by the Institutional Review Board of the Assiut Faculty of Medicine; infertile patients scheduled for laparoscopy were eligible to participate in the study. A written informed consent was obtained. Women were excluded if they had one or more of the following: scar of previous operation, uterine or adnexal mass, history of allergic reaction to study drugs, contraindication for laparoscopic surgery, and history of psychological disturbance or chronic pain before laparoscopy. 2.2. Drug preparation and coding The label of lidocaine vials (DebocaineR. 2% lidocaine Hcl, Al-Nasr pharm. chemicals for Al-Debeiky pharm., – A.R.E., Egypt,) was removed and coded labels were applied instead. Saline containing vials (placebo) were prepared after filling sterile vials with normal saline under complete aseptic precautions, all vials looked the same. A number of vials equal to the sample size were consecutively coded and stored under the appropriate conditions. The code in the treatment envelopes matched the code on the corresponding vial. A computer-based random allocation table was generated. The instructions to use trochar site lidocaine or placebo (Saline 0.9%) were printed out and placed in sealed, opaque, consecutively numbered, and coded envelopes. Data collection sheets with corresponding codes were filled out preoperatively by the operating surgeon. Just after providing consent, the women were given the next number on the random list, which corresponded to an envelope number, and were thus allocated to the lidocaine group (group 1) and control group (group 2). Throughout the trial, access to the randomization code was only available to pharmacist who had performed the randomization and the coding of the envelopes and data sheets. Whether the participants received trochar site saline or lidocaine was concealed from residents. The postoperative data collection was carried out for 24 h by a resident physician, and inquiries about pain were conducted immediately at the recovery room, 2, 4, 6, 24 h, and one week postoperatively. The randomization code of the data sheets was not broken until the completion of the study.
Effect of trochar site lidocaine on postoperative pain scoring and patient satisfaction after gynecologic 2.3. Experimental protocol Laparoscopy in most of the cases was carried out by the first author of this study and in the rest by 2 other Gynecologists, with at least 2 years of laparoscopic experience. Laparoscopy was carried out under general endotracheal intubation anesthesia utilizing propofol 2 mg/kg (pofolÒ, Propofol 1%, Dong kook Pharm. Co.; LTD., packed by Pharco for EIMC pharmaceuticals Co., Egypt), Atracrium 0.5 mg/kg (AtracriumÒ, Atracrium besilate, Galaxo Smith Kline, S.P.A. Italy), and Isoflurane (IsotanÒ, Isoflurane, USP 24, Pharco pharmaceuticals for EIMC pharmaceuticals Co., Egypt). Anesthesia was delivered in most of the cases by the second author of this study and in the rest by 2 other anesthetists with a minimum of 2 years of experience.
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shoulders, and global abdominal pain as pain of an ill-defined site, and/or diffuse as to include more than one abdominal region. 2.7. Patient satisfaction For assessment of patient satisfaction with the overall postoperative care at 24 h, a simple questionnaire was applied to each woman after laparoscopy within 12–24 h according to nursing time and avoiding the patient’s sleeping. The questionnaire was recorded using a 1–100 verbal analog score (VAS) where 0 mm indicated total dissatisfaction and 100 indicated total satisfaction. One question was asked in plain Arabic language: (1) How would you evaluate the overall postoperative experience in respect to what you expected?
2.4. The technique
2.8. Outcome
After proper sterilization of the skin of the abdomen, the Infraumilical skin (the 1st trochar site) was infiltrated by 2.5 cm of lidocaine HCL 2% or saline solution according to allocation of the case in the scheduled area of incision, withdrawal of the plunger of the syringe was recommended to avoid injection into a blood vessel, the skin then incised. CO2 insufflation was done thereafter using the verrus needle followed by introduction of the primary trochar (10 mm). After exploring the pelvis, 2.5 cm of lidocaine HCL 2% or saline were injected in the scheduled site of the 2nd and the 3rd trochar site by the same technique used for the umbilical port followed by introduction of the trochars (5 mm). After completion of the surgery and before trochar removal, intraperitoneal instillation of 5 cc of lidocaine HCL 2% was done from the second port. Closure of the umbilical port was done with single stitch. The 2nd and 3rd trochar site was just approximated and not stitched.
The primary outcome measure was pain severity at trochar sites, shoulder and global abdomen region on the 1st and 7th postoperative days. Secondary outcomes included analgesia needs at the first 24 h, number of patients reporting pain at the 7th postoperative day and after 1 month, and patient satisfaction with the overall postoperative care at 24 h.
2.5. Perioperative analgesia All patients received intramuscular injection of 30 mg ketorolac tromethamine (KetolacÒ, ketorolac tromethamine. AMRIYA Pharm. Industries, Egypt) immediately after endotracheal intubation. Intravenous paracetamol 1 g (perfalganÒ, paracetamol 1000 mg. UPSA laboratories, France), was used for postoperative breakthrough pain. 2.6. Pain scoring All pain scores were obtained during rest. To assess pain on the 1st postoperative day, visual analog scoring (VAS) was used by means of a 10-cm line with verbal anchors saying ‘‘no pain’’ at one end and ‘‘excruciating pain’’ at the other end. VAS was used immediately at the recovery room, at 2, 4, 6, and 24 h after surgery. VAS was performed to assess each of the following: global abdominal pain, shoulder pain and trochar site pain, and a mean pain score of each region were recorded. On the 7th day after surgery at the time of stitch removal, VAS was collected for pain at the same sites. Patients with persistent pain after the 7th day were further contacted through telephone every week to record their numerical rating score (NRS) until pain disappearance or up to one month after surgery. Trochar site pain was defined as pain related to the trochar site incision; shoulder pains as pain related to the
2.9. Sample size, power, and statistical analysis The sample size was calculated for a 1.0-cm difference in VAS for trochar site pain in the first 24 h, with a standard deviation of 1.5 cm, a = 0.05, and b = 0.95. This gave a minimum of 47 women in each group. We included 100 women in each group to account for follow-up losses. Data were analyzed using the SPSS version 17.0 (SPSS, Inc., Chicago, IL). Results were reported as mean ± standard deviation and percentages. The v2-test or, if necessary, the Fisher exact test was used to compare continuous data, and VAS and NRS were compared using the Wilcoxon ranked sum test. P value of less than 0.05 was considered significant. 3. Results We assessed 200 patients for eligibility to participate in the study. 18 patients were excluded for not meeting the inclusion criteria and 22 patients refused to participate. The remaining 160 patients were allocated to two groups, group 1 (n = 80) and group 2 (n = 80), (Fig. 1). Table 1, summarizes the demographic characteristics of patients in both groups. Both groups were comparable as with regard to age, parity, indications for and type laparoscopy and duration of infertility. Table 2, summarizes the effect of trochar site infiltration of lidocaine on postoperative pain scoring in both groups. The control group showed significantly higher trochar sites pain (VAS, 3.2 ± 1.8 vs. 1.8 ± 1.6, P < 0.001) and global abdominal pain (VAS, 3.4 ± 1.7 vs. 2.6 ± 1.6, P < 0.05) on the 1st postoperative day. Shoulder pain scores on the 1st postoperative day did not show significant difference between the two studied groups. The mean VAS on the 7th post operative were higher in the control group (2.1 ± 1.1 and 2.0 ± 0.8) compared to the lidocaine group (1.1 ± 0.7 and 1.1 ± 0.6) for global abdominal pain and trochar site pain, respectively.
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K.M. Zahran et al. Eligible infertile women (n= 200) Excluded (n= 40) Not meeting inclusion criteria (n= 18) Refused to participate (n= 22) Enrollment 160 infertile patients randomized into two groups, using computer generated random numbers
Group I (n= 80), Lidocaine group Trocher site lidocaine 2.5 cc plus intraperitoneal 5 cc of lidocaine 2%
We measured: VAS and patient satisfaction on day 1 NRS on day 7 Follow up of persistence of pain till one month after laparoscopy
Analyzed (n= 80)
Figure 1
Table 1
Allocation
Follow-Up
Group II (n= 80), control group Trocher site saline 2.5 cc plus intraperitoneal 5 cc of lidocaine 2%
We measured: VAS and patient satisfaction on day 1 NRS on day 7 Follow up of persistence of pain till one month after laparoscopy
Analysis
Analyzed (n= 80)
The figure shows a flowchart of study including patients’ enrollment, allocation, follow-up, and analysis.
Demographic characteristic of patients in both groups.
Item
Lidocaine (n = 80)
Control (n = 80)
P value
Age in years Parity
22.4 ± 10.2 0.8 ± 0.4
24.2 ± 12.4 0.6 ± 0.2
NS NS
Indication for laparoscopy Primary infertility Secondary infertility
38 (47.50%) 42 (52.50%)
35 (43.75%) 45 (56.25%)
NS
Duration of infertility (years) Primary infertility Secondary infertility
3.2 ± 1.2 5.8 ± 1.8
3.0 ± 1.2 5.2 ± 1.7
NS
Type of laparoscopy Diagnostic Operative
22 (27.50%) 58 (72.50%)
17 (21.25%) 63 (78.75%)
NS
NS, non significant.
Shoulder pain was not reported in any patient in both groups at the 7th postoperative day. Table 3, summarizes the effect of trochar site infiltration of lidocaine on additional analgesic requirement, patient satisfaction and operative duration. More patients in the control group received analgesia injections (perfalgan) in the first 24 h than in the lidocaine group [42 (52.5%) vs. 20 (25.0%), P < 0.001]. There was no report of any type of pain one month postoperatively in both groups (incidence of chronic pain development was 0% in both groups). Patients in the lidocaine group reported higher satisfaction score with the overall postoperative care in the first 24 h. There was no difference between both groups regarding the operative duration.
Table 4, summarizes postoperative complications in both groups. There were no statistically significant differences between the groups regarding postoperative nausea and/or vomiting, retention of urine, trochar site bleeding or trochar site infection. 4. Discussion The establishment of laparoscopic gynecological procedures as routine outpatient surgeries values questing safe, reliable and effective methods for good postoperative analgesia that do not delay patient discharge (17). The main finding in our study was that the combined use of somatic and visceral lidocaine blockade reduced global abdominal and trochar sites pain, improved patient satisfac-
Effect of trochar site lidocaine on postoperative pain scoring and patient satisfaction after gynecologic Table 2 Effect of trochar site infiltration of lidocaine on postoperative pain scoring. Item
Control (n = 80)
P value
VAS for global abdominal pain 24 h 2.6 ± 1.6 One week 1.1 ± 0.7
Lidocaine (n = 80)
3.4 ± 1.7 2.1 ± 1.1
0.03 0.01
VAS for trochar site pain 24 h 1.8 ± 1.6 One week 1.1 ± 0.6
3.2 ± 1.8 2.0 ± 0.8
0.001 0.01
VAS for shoulder pain 24 h 1.0 ± 0.2 One week 0.0
1.2 ± 0.4 0.0
NS –
NS, non significant.
Table 3 Effect of trochar site infiltration of lidocaine on analgesia requirement, patient satisfaction and operative duration. Item
Lidocaine (n = 80)
Control (n = 80)
P value
Need for postoperative analgesia Patient satisfaction Operative duration (min)a
20 (25.0%)
42 (52.5%)
0.001
85.0 ± 13.2 26.2 ± 8.2
67.2 ± 8.3 25.4 ± 7.8
0.04 NS
NS, non significant. a Operative duration reported from gas insufflation till removal of the trochars.
Table 4
Postoperative complications in both groups.
Item
Lidocaine (n = 80)
Control (n = 80)
P value
Nausea and/or vomiting Retention of urine Trochar site bleeding Trochar site infection
6 (7.50%)
7 (8.75%)
NS
3 (3.75%) 2 (2.50%) 2 (2.50%)
3 (3.75%) 1 (1.25%) 2 (2.50%)
NS NS NS
NS, non significant.
tion, and decreased patients’ breakthrough pain analgesics merits during the first 24 postoperative hours. Many studies have described pain according to its mechanism: visceral or scapular pain can theoretically be blocked by intraperitoneal L.A infiltration; and parietal pain, can be blocked by trochar site L.A infiltration (18,19). Our data confirms that scapular and visceral pains are blocked by intraperitoneal lidocaine installation. However, we described that global abdominal pain in spite of its visceral nature, trochar site lidocaine infiltration had an additional analgesic action on this pain which is difficult to explain. A systemic analgesic action from intraperitoneal and trochar site injected lidocaine cannot be overlooked. IV lidocaine can be effective in visceral pain, and its effectiveness seems to be dose related: small doses are almost ineffective, and large doses produce almost total inhibition in some experimental models (20). In our study the total lidocaine dose when used for combined visceral and parietal block was higher than that used for visceral block alone, and this may at least in part explain the
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additional analgesic effect of trochar site infiltration on visceral global abdominal pain. Another explanation would be that lidocaine trochar site infiltration improved the overall pain control which may have decreased development of acute central sensitization. The enhanced responsiveness of nociceptive neurons in the central nervous system has been termed central sensitization (21). Central sensitization takes place within the dorsal horn of the spinal cord, the brain stem, and the brain. Central sensitization allows normal low-threshold mechanoreceptors to produce pain as a result of changes in sensory processing in the spinal cord (22). If trochar site lidocaine infiltration would decrease development of acute central sensitization, thus it would decrease all types of pain perception including visceral pain perception in spite of blocking parietal pain perception in first place. Also the share of trochar site infiltration into an overall better patient satisfaction, less depression and anxiety, consequently better tolerability of the visceral pain element as well. Patients with higher levels of anxiety and depression experience increased pain scores (23,24). Trochar site lidocaine infiltration reduced pain reporting at the 7th post operative day for both global abdominal and trochar site pain. Better 1st day post operative pain control and less central sensitization development are claimed to explain these results. Shahin and Osman 2009 reported that higher pain scores at the 1st post operative day lead to higher pain scores at day 15 when studying pain after cesarean section and attributed central sensitization development as a core mechanism (15). Our study demonstrated that chronic pain is very uncommon to develop after laparoscopic gynecological procedures. This can be attributed to the minimal invasive nature of these surgeries and to its mild to moderate postoperative pain. We conclude that the combined use somatic (trochar site) and visceral (intraperitoneal) lidocaine blockade is superior to intraperitoneal lidocaine alone in managing postoperative pain for laparoscopic gynecological procedures. It led to lower VAS scores, less need for additional analgesics and higher patient satisfaction. 5. Conflicts of interest The authors declare that they have no conflicts of interest. References (1) Di Pace MR, Cimador M, Catalano P, Caruso A, Sergio M, Casuccio A, De Grazia E. Efficacy of periportal infiltration and intraperitoneal instillation of ropivacaine after laparoscopic surgery in children. J Laparoendosc Adv Surg Tech A 2009;19(6):821–5. (2) Nathanson LK, Shimi S, Cuschieri A. Laparoscopic cholecystectomy: the Dundee technique. Br J Surg 1991;78:155–9. (3) Moiniche S, Jorgensen H, Wetterslev J, Dahl JB. Local anesthetic infiltration for postoperative pain relief after laparoscopy: a qualitative and quantitative systematic review of intraperitoneal, port-side infiltration and mesosalpinx block. Anesth Analg 2000;90:899–912. (4) Fredman MB BCh Brian, Jedeikin MB ChB, FFA(SA) Robert, Olsfanger MB, ChB David, Hor MD Phillip, Gruzman MD Aaron. Residual pneumoperitoneum: a cause of postoperative pain after laparoscopic cholecystectomy. Anesth Analg 1994;79: 152–4.
136 (5) Ng A, Smith G. Intraperitoneal administration of analgesia: is this practice of any utility? Br J Anaesth 2002;4:535–7. (6) Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy. A critical assessment of the evidence. Anesthesiology 2006;104:835–46. (7) Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg 2006:103. (8) Chou YJ, Ou YC, Lan KC, et al. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol 2005;12:330–5. (9) Elhakim M, Elkott M, Ali NM, et al. Intraperitoneal lidocaine for postoperative pain after laparoscopy. Acta Anaesthesiol Scand 2000;44:280–4. (10) Griffiths AB, Singh S, Fiennes AGTW. In: Perissat J, editor. 3rd World Congress of Endoscopic Surgery, Bordeaux, June 18–20, 1992. Surg Laparosc Endosc 1993;3:27. (11) Gupta A. Local anaesthesia for pain relief after laparoscopic cholecystectomy––a systematic review. Best Pract Res Clin Anaesthesiol 2005;19(2):275–92. (12) Macrae WA. Chronic pain after surgery. Br J Anaesth 2001;87:88–98. (13) Lavand’homme P. Postcesarean analgesia: effective strategies and association with chronic pain. Curr Opin Anaesthesiol 2006;19:244–8. (14) Nikolajsen L, Sensen HC, Jensen TS, et al. Chronic pain following Caesarean section. Acta Anaesthesiol Scand 2004;48:111–6.
K.M. Zahran et al. (15) Shahin AY, Osman AM. Parietal peritoneal closure and persistent postcesarean pain. Int J Gynecol Obstet 2009;104: 135–9. (16) Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet 2006;367:1618–25. (17) Warrick Paul D, Belo Susan E. Treating ‘‘rebound’’ emesis following outpatient gynecologic laparoscopy: the efficacy of a two-dose regimen of droperidol and ondansetron. J Clin Anesth 1999;11(2):119–25. (18) Kehlet H, Rung GW, Callesen T. Postoperative opioid analgesia: time for a reconsideration? J Clin Anesth 1996;8:441–5. (19) Fredman B, Jedeikin R, Olsfanger D, et al. Residual pneumoperitoneum: a cause of postoperative pain after laparoscopic cholecystectomy. Anesth Analg 1994;79:152–4. (20) Ness TJ. Intravenous lidocaine inhibits visceral nociceptive reflexes and spinal neurons in the rat. Anesthesiology 2000;92:1685–91. (21) Willis WD. Long-term potentiation in spinothalamic neurons. Brain Res Rev 2002;40(1–3):202–14. (22) Basbaum AI. Spinal mechanisms of acute and persistent pain. Reg Anesth Pain Med 1999;24(1):59–67. (23) Haythornthwaite JA, Menefee LA, Heinberg LJ, et al. Pain coping strategies predict perceived control over pain. J Pain 1998;77:33–9. (24) Taenzer P, Melzack R, Jeans ME. Influence of psychological factors on postoperative pain, mood and analgesic requirements. J Pain 1986;24:331–42.
Middle East Fertility Society
Middle East Fertility Society Journal www.mefsjournal.com www.sciencedirect.com
ORIGINAL ARTICLE
Effect of trochar site lidocaine on postoperative pain scoring and patient satisfaction after gynecologic laparoscopies – A randomized clinical trial Kamal M. Zahran a b c
a,*
, Ayman M. Osman b, Jelan A. Abd Elaleem
c
Department of Obstetrics and Gynecology, Women’s Health Centre, Assiut University, Egypt Department of Anesthesia and Intensive Care, Assiut University, Egypt Department of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Egypt
Received 5 October 2010; accepted 10 December 2010 Available online 22 January 2011
KEYWORDS Trochar site lidocaine; Postoperative pain; Gynecologic laparoscopies
Abstract Objective: To assess the effectiveness of lidocaine infiltrated at trochar sites on postoperative pain scoring and patient satisfaction after gynecological laparoscopies. Methods: 160 infertile women scheduled for laparoscopy were randomized to have intraperitoneal lidocaine alone or intraperitoneal lidocaine combined with lidocaine infiltrated at trochar sites. Visual analog score (VAS) was used for assessment of pain severity at trochar sites, shoulder and global abdomen regions on the 1st and 7th postoperative days and verbal analog scoring was used to asses patient satisfaction. Results: Women who received intraperitoneal lidocaine alone showed significantly higher VAS scores at trochar site (3.2 ± 1.8 vs. 1.8 ± 1.6) and global abdominal region (3.4 ± 1.7 vs. 2.6 ± 1.6) on the 1st postoperative day. Shoulder pain scores did not show significant difference between the two groups. Patients who received intraperitoneal lidocaine combined with lidocaine infiltrated at the trochar sites reported higher satisfaction score with the overall postoperative care in the first 24 h.
* Corresponding author. Tel.: +20 882 41 4616, mobile: +20 127432270, priv.: +20 889203555; fax: +20 882 368377. E-mail address: [email protected] (K.M. Zahran). 1110-5690 Ó 2011 Middle East Fertility Society. Production and hosting by Elsevier B.V. All rights reserved. Peer review under responsibility of Middle East Fertility Society. doi:10.1016/j.mefs.2010.12.004
Production and hosting by Elsevier
132
K.M. Zahran et al. Conclusion: The combined use trochar sites and intraperitoneal lidocaine is superior to intraperitoneal lidocaine alone in managing postoperative pain after laparoscopic gynecological procedures. It leads to lower VAS at day 1 and day 7 postoperatively, less need for additional analgesics and higher patient satisfaction. Ó 2011 Middle East Fertility Society. Production and hosting by Elsevier B.V. All rights reserved.
1. Introduction Postoperative pain is less intense after laparoscopic than open surgery. However, minimally invasive surgery is not a pain-free procedure (1). The cause of postoperative pain after laparoscopic surgeries is multifactorial, visceral pain and residual pneumoperitoneum are major contributors (2–4). The intraperitoneal (IP) administration of local anesthetic (LA) during gynecologic laparoscopies results in improved initial pain relief and opioid dose sparing (5). However, a systematic review of IP bupivacaine administration for laparoscopic cholecystectomy found nine negative and 15 positive trials for significant analgesic benefit and concluded that, because of the low study quality and conflicting results, the use of IP LA could not be recommended (6). Another systematic review found IP LA significantly reduced pain scores at 4 h (7). Blocking peritoneal afferents via Instillation of local anesthetics intraperitoneally is claimed to have beneficial effect after gynecologic laparoscopic surgeries (8,9). Local anesthetic infiltration of the incision sites decreases postoperative opiate requirement and improves subjective pain scores but does not entirely eliminate the pain (10). Combination of local infiltration and intraperitoneal instillation of ropivacaine is more effective for pain relief in children after laparoscopic surgery than the administration of ropivacaine only at the trochar sites (1). Five of six studies in which LA were injected locally found beneficial effects on postoperative pain but not analgesic consumption for up to 24 h postoperatively. When injected intraperitoneally, 14 of 23 studies found a reduction in pain scores in the LA group but only 9 of 21 found a reduction in analgesic consumption (11). Twenty percent of chronic pain patients implicate surgery as one of the causes of their chronic pain and, in about half of them; it was the sole cause (12). Recalling of severe acute postoperative pain was among the risk factors for development of chronic pain (13). Recent reports showed the overall incidence of chronic postcesarean pain to vary between 12.3% (14) and 17.8% (15). Strategies to reduce chronic postsurgical pain include utilizing minimally invasive surgical techniques to avoid nerve damage and using local anesthetics (16). Postoperative pain after laparoscopic surgery is less than after laparotomy, and patients may benefit from peripheral use of local anesthetic as in case of minor open procedures. Peripheral use of local anesthetic may include both intraperitoneal instillation and port site infiltration (3). We aimed to assess the effectiveness and safety of lidocaine infiltrated at the trochar site on postoperative pain scoring, patient satisfaction and incidence of chronic pain development after gynecologic laparoscopies. In the current work lidocaine was used via both its infiltration at the port wound site and its intraperitoneal instillation for the management of post operative pain after gynecological laparoscopies. We hypothesize that port site infiltration and intraperitoneal instillation of
lidocaine will block both somatic and visceral pain elements, respectively. Patients in the current study were also observed for the incidence of chronic pain development after such a minor procedure. 2. Materials and methods 2.1. Eligibility and randomization This randomized double-blind placebo-controlled clinical study took place at the Women’s Health Centre, Assiut University, from November 2008 through April 2010. The study was approved by the Institutional Review Board of the Assiut Faculty of Medicine; infertile patients scheduled for laparoscopy were eligible to participate in the study. A written informed consent was obtained. Women were excluded if they had one or more of the following: scar of previous operation, uterine or adnexal mass, history of allergic reaction to study drugs, contraindication for laparoscopic surgery, and history of psychological disturbance or chronic pain before laparoscopy. 2.2. Drug preparation and coding The label of lidocaine vials (DebocaineR. 2% lidocaine Hcl, Al-Nasr pharm. chemicals for Al-Debeiky pharm., – A.R.E., Egypt,) was removed and coded labels were applied instead. Saline containing vials (placebo) were prepared after filling sterile vials with normal saline under complete aseptic precautions, all vials looked the same. A number of vials equal to the sample size were consecutively coded and stored under the appropriate conditions. The code in the treatment envelopes matched the code on the corresponding vial. A computer-based random allocation table was generated. The instructions to use trochar site lidocaine or placebo (Saline 0.9%) were printed out and placed in sealed, opaque, consecutively numbered, and coded envelopes. Data collection sheets with corresponding codes were filled out preoperatively by the operating surgeon. Just after providing consent, the women were given the next number on the random list, which corresponded to an envelope number, and were thus allocated to the lidocaine group (group 1) and control group (group 2). Throughout the trial, access to the randomization code was only available to pharmacist who had performed the randomization and the coding of the envelopes and data sheets. Whether the participants received trochar site saline or lidocaine was concealed from residents. The postoperative data collection was carried out for 24 h by a resident physician, and inquiries about pain were conducted immediately at the recovery room, 2, 4, 6, 24 h, and one week postoperatively. The randomization code of the data sheets was not broken until the completion of the study.
Effect of trochar site lidocaine on postoperative pain scoring and patient satisfaction after gynecologic 2.3. Experimental protocol Laparoscopy in most of the cases was carried out by the first author of this study and in the rest by 2 other Gynecologists, with at least 2 years of laparoscopic experience. Laparoscopy was carried out under general endotracheal intubation anesthesia utilizing propofol 2 mg/kg (pofolÒ, Propofol 1%, Dong kook Pharm. Co.; LTD., packed by Pharco for EIMC pharmaceuticals Co., Egypt), Atracrium 0.5 mg/kg (AtracriumÒ, Atracrium besilate, Galaxo Smith Kline, S.P.A. Italy), and Isoflurane (IsotanÒ, Isoflurane, USP 24, Pharco pharmaceuticals for EIMC pharmaceuticals Co., Egypt). Anesthesia was delivered in most of the cases by the second author of this study and in the rest by 2 other anesthetists with a minimum of 2 years of experience.
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shoulders, and global abdominal pain as pain of an ill-defined site, and/or diffuse as to include more than one abdominal region. 2.7. Patient satisfaction For assessment of patient satisfaction with the overall postoperative care at 24 h, a simple questionnaire was applied to each woman after laparoscopy within 12–24 h according to nursing time and avoiding the patient’s sleeping. The questionnaire was recorded using a 1–100 verbal analog score (VAS) where 0 mm indicated total dissatisfaction and 100 indicated total satisfaction. One question was asked in plain Arabic language: (1) How would you evaluate the overall postoperative experience in respect to what you expected?
2.4. The technique
2.8. Outcome
After proper sterilization of the skin of the abdomen, the Infraumilical skin (the 1st trochar site) was infiltrated by 2.5 cm of lidocaine HCL 2% or saline solution according to allocation of the case in the scheduled area of incision, withdrawal of the plunger of the syringe was recommended to avoid injection into a blood vessel, the skin then incised. CO2 insufflation was done thereafter using the verrus needle followed by introduction of the primary trochar (10 mm). After exploring the pelvis, 2.5 cm of lidocaine HCL 2% or saline were injected in the scheduled site of the 2nd and the 3rd trochar site by the same technique used for the umbilical port followed by introduction of the trochars (5 mm). After completion of the surgery and before trochar removal, intraperitoneal instillation of 5 cc of lidocaine HCL 2% was done from the second port. Closure of the umbilical port was done with single stitch. The 2nd and 3rd trochar site was just approximated and not stitched.
The primary outcome measure was pain severity at trochar sites, shoulder and global abdomen region on the 1st and 7th postoperative days. Secondary outcomes included analgesia needs at the first 24 h, number of patients reporting pain at the 7th postoperative day and after 1 month, and patient satisfaction with the overall postoperative care at 24 h.
2.5. Perioperative analgesia All patients received intramuscular injection of 30 mg ketorolac tromethamine (KetolacÒ, ketorolac tromethamine. AMRIYA Pharm. Industries, Egypt) immediately after endotracheal intubation. Intravenous paracetamol 1 g (perfalganÒ, paracetamol 1000 mg. UPSA laboratories, France), was used for postoperative breakthrough pain. 2.6. Pain scoring All pain scores were obtained during rest. To assess pain on the 1st postoperative day, visual analog scoring (VAS) was used by means of a 10-cm line with verbal anchors saying ‘‘no pain’’ at one end and ‘‘excruciating pain’’ at the other end. VAS was used immediately at the recovery room, at 2, 4, 6, and 24 h after surgery. VAS was performed to assess each of the following: global abdominal pain, shoulder pain and trochar site pain, and a mean pain score of each region were recorded. On the 7th day after surgery at the time of stitch removal, VAS was collected for pain at the same sites. Patients with persistent pain after the 7th day were further contacted through telephone every week to record their numerical rating score (NRS) until pain disappearance or up to one month after surgery. Trochar site pain was defined as pain related to the trochar site incision; shoulder pains as pain related to the
2.9. Sample size, power, and statistical analysis The sample size was calculated for a 1.0-cm difference in VAS for trochar site pain in the first 24 h, with a standard deviation of 1.5 cm, a = 0.05, and b = 0.95. This gave a minimum of 47 women in each group. We included 100 women in each group to account for follow-up losses. Data were analyzed using the SPSS version 17.0 (SPSS, Inc., Chicago, IL). Results were reported as mean ± standard deviation and percentages. The v2-test or, if necessary, the Fisher exact test was used to compare continuous data, and VAS and NRS were compared using the Wilcoxon ranked sum test. P value of less than 0.05 was considered significant. 3. Results We assessed 200 patients for eligibility to participate in the study. 18 patients were excluded for not meeting the inclusion criteria and 22 patients refused to participate. The remaining 160 patients were allocated to two groups, group 1 (n = 80) and group 2 (n = 80), (Fig. 1). Table 1, summarizes the demographic characteristics of patients in both groups. Both groups were comparable as with regard to age, parity, indications for and type laparoscopy and duration of infertility. Table 2, summarizes the effect of trochar site infiltration of lidocaine on postoperative pain scoring in both groups. The control group showed significantly higher trochar sites pain (VAS, 3.2 ± 1.8 vs. 1.8 ± 1.6, P < 0.001) and global abdominal pain (VAS, 3.4 ± 1.7 vs. 2.6 ± 1.6, P < 0.05) on the 1st postoperative day. Shoulder pain scores on the 1st postoperative day did not show significant difference between the two studied groups. The mean VAS on the 7th post operative were higher in the control group (2.1 ± 1.1 and 2.0 ± 0.8) compared to the lidocaine group (1.1 ± 0.7 and 1.1 ± 0.6) for global abdominal pain and trochar site pain, respectively.
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K.M. Zahran et al. Eligible infertile women (n= 200) Excluded (n= 40) Not meeting inclusion criteria (n= 18) Refused to participate (n= 22) Enrollment 160 infertile patients randomized into two groups, using computer generated random numbers
Group I (n= 80), Lidocaine group Trocher site lidocaine 2.5 cc plus intraperitoneal 5 cc of lidocaine 2%
We measured: VAS and patient satisfaction on day 1 NRS on day 7 Follow up of persistence of pain till one month after laparoscopy
Analyzed (n= 80)
Figure 1
Table 1
Allocation
Follow-Up
Group II (n= 80), control group Trocher site saline 2.5 cc plus intraperitoneal 5 cc of lidocaine 2%
We measured: VAS and patient satisfaction on day 1 NRS on day 7 Follow up of persistence of pain till one month after laparoscopy
Analysis
Analyzed (n= 80)
The figure shows a flowchart of study including patients’ enrollment, allocation, follow-up, and analysis.
Demographic characteristic of patients in both groups.
Item
Lidocaine (n = 80)
Control (n = 80)
P value
Age in years Parity
22.4 ± 10.2 0.8 ± 0.4
24.2 ± 12.4 0.6 ± 0.2
NS NS
Indication for laparoscopy Primary infertility Secondary infertility
38 (47.50%) 42 (52.50%)
35 (43.75%) 45 (56.25%)
NS
Duration of infertility (years) Primary infertility Secondary infertility
3.2 ± 1.2 5.8 ± 1.8
3.0 ± 1.2 5.2 ± 1.7
NS
Type of laparoscopy Diagnostic Operative
22 (27.50%) 58 (72.50%)
17 (21.25%) 63 (78.75%)
NS
NS, non significant.
Shoulder pain was not reported in any patient in both groups at the 7th postoperative day. Table 3, summarizes the effect of trochar site infiltration of lidocaine on additional analgesic requirement, patient satisfaction and operative duration. More patients in the control group received analgesia injections (perfalgan) in the first 24 h than in the lidocaine group [42 (52.5%) vs. 20 (25.0%), P < 0.001]. There was no report of any type of pain one month postoperatively in both groups (incidence of chronic pain development was 0% in both groups). Patients in the lidocaine group reported higher satisfaction score with the overall postoperative care in the first 24 h. There was no difference between both groups regarding the operative duration.
Table 4, summarizes postoperative complications in both groups. There were no statistically significant differences between the groups regarding postoperative nausea and/or vomiting, retention of urine, trochar site bleeding or trochar site infection. 4. Discussion The establishment of laparoscopic gynecological procedures as routine outpatient surgeries values questing safe, reliable and effective methods for good postoperative analgesia that do not delay patient discharge (17). The main finding in our study was that the combined use of somatic and visceral lidocaine blockade reduced global abdominal and trochar sites pain, improved patient satisfac-
Effect of trochar site lidocaine on postoperative pain scoring and patient satisfaction after gynecologic Table 2 Effect of trochar site infiltration of lidocaine on postoperative pain scoring. Item
Control (n = 80)
P value
VAS for global abdominal pain 24 h 2.6 ± 1.6 One week 1.1 ± 0.7
Lidocaine (n = 80)
3.4 ± 1.7 2.1 ± 1.1
0.03 0.01
VAS for trochar site pain 24 h 1.8 ± 1.6 One week 1.1 ± 0.6
3.2 ± 1.8 2.0 ± 0.8
0.001 0.01
VAS for shoulder pain 24 h 1.0 ± 0.2 One week 0.0
1.2 ± 0.4 0.0
NS –
NS, non significant.
Table 3 Effect of trochar site infiltration of lidocaine on analgesia requirement, patient satisfaction and operative duration. Item
Lidocaine (n = 80)
Control (n = 80)
P value
Need for postoperative analgesia Patient satisfaction Operative duration (min)a
20 (25.0%)
42 (52.5%)
0.001
85.0 ± 13.2 26.2 ± 8.2
67.2 ± 8.3 25.4 ± 7.8
0.04 NS
NS, non significant. a Operative duration reported from gas insufflation till removal of the trochars.
Table 4
Postoperative complications in both groups.
Item
Lidocaine (n = 80)
Control (n = 80)
P value
Nausea and/or vomiting Retention of urine Trochar site bleeding Trochar site infection
6 (7.50%)
7 (8.75%)
NS
3 (3.75%) 2 (2.50%) 2 (2.50%)
3 (3.75%) 1 (1.25%) 2 (2.50%)
NS NS NS
NS, non significant.
tion, and decreased patients’ breakthrough pain analgesics merits during the first 24 postoperative hours. Many studies have described pain according to its mechanism: visceral or scapular pain can theoretically be blocked by intraperitoneal L.A infiltration; and parietal pain, can be blocked by trochar site L.A infiltration (18,19). Our data confirms that scapular and visceral pains are blocked by intraperitoneal lidocaine installation. However, we described that global abdominal pain in spite of its visceral nature, trochar site lidocaine infiltration had an additional analgesic action on this pain which is difficult to explain. A systemic analgesic action from intraperitoneal and trochar site injected lidocaine cannot be overlooked. IV lidocaine can be effective in visceral pain, and its effectiveness seems to be dose related: small doses are almost ineffective, and large doses produce almost total inhibition in some experimental models (20). In our study the total lidocaine dose when used for combined visceral and parietal block was higher than that used for visceral block alone, and this may at least in part explain the
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additional analgesic effect of trochar site infiltration on visceral global abdominal pain. Another explanation would be that lidocaine trochar site infiltration improved the overall pain control which may have decreased development of acute central sensitization. The enhanced responsiveness of nociceptive neurons in the central nervous system has been termed central sensitization (21). Central sensitization takes place within the dorsal horn of the spinal cord, the brain stem, and the brain. Central sensitization allows normal low-threshold mechanoreceptors to produce pain as a result of changes in sensory processing in the spinal cord (22). If trochar site lidocaine infiltration would decrease development of acute central sensitization, thus it would decrease all types of pain perception including visceral pain perception in spite of blocking parietal pain perception in first place. Also the share of trochar site infiltration into an overall better patient satisfaction, less depression and anxiety, consequently better tolerability of the visceral pain element as well. Patients with higher levels of anxiety and depression experience increased pain scores (23,24). Trochar site lidocaine infiltration reduced pain reporting at the 7th post operative day for both global abdominal and trochar site pain. Better 1st day post operative pain control and less central sensitization development are claimed to explain these results. Shahin and Osman 2009 reported that higher pain scores at the 1st post operative day lead to higher pain scores at day 15 when studying pain after cesarean section and attributed central sensitization development as a core mechanism (15). Our study demonstrated that chronic pain is very uncommon to develop after laparoscopic gynecological procedures. This can be attributed to the minimal invasive nature of these surgeries and to its mild to moderate postoperative pain. We conclude that the combined use somatic (trochar site) and visceral (intraperitoneal) lidocaine blockade is superior to intraperitoneal lidocaine alone in managing postoperative pain for laparoscopic gynecological procedures. It led to lower VAS scores, less need for additional analgesics and higher patient satisfaction. 5. Conflicts of interest The authors declare that they have no conflicts of interest. References (1) Di Pace MR, Cimador M, Catalano P, Caruso A, Sergio M, Casuccio A, De Grazia E. Efficacy of periportal infiltration and intraperitoneal instillation of ropivacaine after laparoscopic surgery in children. J Laparoendosc Adv Surg Tech A 2009;19(6):821–5. (2) Nathanson LK, Shimi S, Cuschieri A. Laparoscopic cholecystectomy: the Dundee technique. Br J Surg 1991;78:155–9. (3) Moiniche S, Jorgensen H, Wetterslev J, Dahl JB. Local anesthetic infiltration for postoperative pain relief after laparoscopy: a qualitative and quantitative systematic review of intraperitoneal, port-side infiltration and mesosalpinx block. Anesth Analg 2000;90:899–912. (4) Fredman MB BCh Brian, Jedeikin MB ChB, FFA(SA) Robert, Olsfanger MB, ChB David, Hor MD Phillip, Gruzman MD Aaron. Residual pneumoperitoneum: a cause of postoperative pain after laparoscopic cholecystectomy. Anesth Analg 1994;79: 152–4.
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