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Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial
Accepted Manuscript Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, DoubleBlind Randomized Trial Ghassan Elamin, MRCSI, Peadar S. Waters, MD, Hytham Hamid, MRCSI, Hannah M. O'Keeffe, MB, BCH BAO, Ronan M. Waldron, MB, BCH BAO, Michelle Duggan, FRCA, Waqar Khan, FRCSI, Michael Kevin Barry, MBBCh, FRCSI, FACS, Iqbal Z. Khan, FRCSI PII:
S1072-7515(15)00235-5
DOI:
10.1016/j.jamcollsurg.2015.03.030
Reference:
ACS 7852
To appear in:
Journal of the American College of Surgeons
Received Date: 8 January 2015 Revised Date:
1 March 2015
Accepted Date: 3 March 2015
Please cite this article as: Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ, Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial, Journal of the American College of Surgeons (2015), doi: 10.1016/j.jamcollsurg.2015.03.030. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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ACCEPTED MANUSCRIPT Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block
Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial
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Ghassan Elamin, MRCSI(1), Peadar S Waters, MD(1), Hytham Hamid, MRCSI(1), Hannah M. O'Keeffe, MB, BCH BAO(1); Ronan M Waldron, MB, BCH BAO(1), Michelle Duggan, FRCA (2); Waqar Khan, FRCSI(1), Michael Kevin Barry, MBBCh, FRCSI, FACS(1)(3);
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Iqbal Z Khan, FRCSI(1)
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1. Department of Surgery, Mayo General Hospital, Castlebar, Mayo, Ireland. 2. Discipline of Anaesthesia, Mayo General Hospital, Castlebar, Mayo, Ireland. 3. Professor of Surgery, National University of Ireland Galway
Peadar S Waters, MD,
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Correspondence address:
Department of Surgery, Mayo General Hospital, Castlebar, Mayo, Ireland.
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[email protected]
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Phone: 00353949021733
Disclosure Information: Nothing to disclose. Trial registration number: ISRCTN46581210.
Abstract presented at the American College of Surgeons 100th Annual Clinical Congress, San Francisco, CA, October 2014.
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Short title: Transversus Abdominis Plane Block Technique
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ACCEPTED MANUSCRIPT Background: The management of post-operative pain is paramount in order to facilitate the delivery of day case surgical programmes. In recent years, the complexity of procedures
carried out has increased to include laparoscopic cholecystectomy (LC). The aim of this study is to evaluate the impact of laparoscopic-assisted four-quadrant transversus abdominis plane
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(TAP) block versus peri-portal local anaesthetic wound infiltration in managing postoperative pain.
Study Design: A prospective, randomized, double-blinded trial was performed on patients
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undergoing elective LC. Patients were randomised using computerised “random number
table” into a Test group which received laparoscopic-assisted TAP block with bupivacaine
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with peri-portal saline injection and a Control group which received a laparoscopic-assisted TAP block with saline and peri-portal bupivacaine. All patients received intra-peritoneal instillation of Bupivacaine in the gallbladder bed. Postoperative pain scores were recorded using Numerical Rating Scores (NRS) at rest and coughing at dedicated time points.
significant.
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Statistical analysis was carried out using GraphPad PrismV.5 with p<0.05 considered
Results: Eighty patients, (70f, 10m) were enrolled with 40 patients randomised to each
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group. Age, ASA score, operative time and BMI were comparable between both groups. No
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adverse events were encountered with the administration of TAP blocks. NRS were significantly reduced in the Test group at 1, 3 and 6 hours at rest (p=0.025, 0.03, 0.007) respectively.NRS was significantly reduced at 1, 3 and 6 hours during coughing (p=0.026, 0.02, 0.03) respectively. Difference in post-operative analgesic requirements between both groups was statistically insignificant (p=0.17). Conclusions: This analysis has confirmed the therapeutic benefit of laparoscopically delivered TAP blocks in elective LC.
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ACCEPTED MANUSCRIPT Effective analgesia is an essential part of postoperative management. Adequate pain control is crucial as it enhances early recovery and facilitates the discharge of a satisfied patient. Furthermore it enables early patient mobilisation and prevents post-operative complications such as deep vein thrombosis, pulmonary embolus, pulmonary atelectasis and constipation.
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Local anaesthesia (LA) has been and is still widely considered an important component of the multi-modal analgesic ladder used to achieve optimum pain control following abdominal surgery. Transversus Abdominis Plane block technique (TAP Block) is one such intervention
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in which the local anaesthetic is infiltrated in the fascial plane between the internal oblique and Transversus abdominis muscles where the somatic nerves from T6 to L1 run to innervate
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the anterior abdominal wall layers from the skin to the parietal peritoneum. First described in 2001, a blind “double pop” technique of infiltration was employed to deliver LA into the appropriate site1. The effectiveness of this blind technique is dependent on the administrator noting the pops while the needle traverses the outer two muscles before
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reaching the correct plane. Due to its blind nature and the fact that outcome was heavily reliant on operator competence, further adjuncts were sought to improve accurate delivery of LA into the appropriate plane. The use of an ultrasound guided technique of administration
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was introduced in 2007 which provided the operator with a clear visualisation of the fascial
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planes and needle upon penetration of the individual layers2. In current practice both techniques are commonly carried out by senior anaesthetists with the necessary specialised skill set in regional anaesthesia and ultrasound machine use. The process of delivering a more accurate TAP block by using a laparoscopic assisted technique was investigated in 2011 while carrying out laparoscopic nephrectomies3. The authors confirmed infiltration into the correct plane by visualising the formation of Doyle’s bulge utilizing the presence of the laparoscope camera within the peritoneal cavity. This technique prevented intra-peritoneal
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ACCEPTED MANUSCRIPT infiltration of the LA and proved to be faster and eliminated the need for a specialised skill set and an ultrasound machine. To date there are limited studies analysing the benefit of TAP blocks in laparoscopic cholecystectomy. Results of such limited studies have been conflicting when comparing
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ultrasound guided TAP blocks to conventional peri-portal infiltration for post-operative pain control 4- 6. Currently there are no trials in the literature examining the role of
laparoscopically assisted TAP blocks for the management of peri-operative pain in
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laparoscopic cholecystectomy. With this in mind, the aim of this study was to investigate the benefit of four point laparoscopic assisted TAP blocks compared to conventional and widely
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used peri-portal infiltration of local anaesthesia in patients undergoing elective laparoscopic cholecystectomy. METHODS
This study was conducted in the Department of General surgery at Mayo General Hospital,
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Ireland from May 2013 to March 2014. Mayo General Hospital is a teaching hospital affiliated to the National University of Ireland Galway. Sample size was calculated; 16 patients were required in each arm to reach power of 80%. Reevaluation was performed at 30
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(Figure 1).
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and to avoid type II error, sample size was expanded to 80 with 40 patients in each arm
Inclusion criteria
All consecutive ASA grade I-II patients undergoing elective laparoscopic cholecystectomy between the ages of 18 to 85 years. Exclusion criteria •
Emergency laparoscopic cholecystectomy.
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ASA grade III, IV, V
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Conversion to open procedures.
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ACCEPTED MANUSCRIPT Coagulopathy.
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Significant liver or renal disease.
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Allergy to Bupivacaine.
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Diagnosis of chronic pain syndrome.
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Known alcohol or substance abuse within the last 6 months.
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Daily Opioid intake.
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Abdominal drain use.
Test group - received laparoscopic assisted TAP block with bupivacaine and periportal sterile saline.
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•
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The patients were randomized into two groups:
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•
Control group - received laparoscopic assisted TAP block with sterile saline and periportal infiltration of bupivacaine.
Using a computerised “random number table” technique, a randomisation list was generated
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and patients were allocated following the list order on the day of admission. The procedure and intervention was explained to each patient by the admitting doctor and informed consent obtained prior to transfer to theatre.
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Prior to randomisation three syringes sets were prepared (Table 1):
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1. 15mls syringes X 2 + 10 mL syringes X 2 for infiltration of the four point TAP Block. 2. 20 ml syringe X 1 for peri-portal infiltration. 3. 10 mL syringe for gall bladder bed infiltration. Both the operating and the anaesthetic teams were blind to the intervention received by the patient. After randomisation, patients were assigned into each group to receive:Intervention After induction of anaesthesia, 7mls of the 20mls syringe was infiltrated into the umbilical port site just before making the skin incision. Following the insertion of this port a pneumo-
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ACCEPTED MANUSCRIPT peritonium was created with pressure standardized to 12MMHg for all patients. At this point with the aid of direct visualisation of peritoneum with the laparoscope, Tap Blocks were instilled using a 22G needle at four points as follows: •
Bilateral subcostal infiltration between anterior axillary and mid clavicular lines - 10
•
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mL each.
Bilateral infiltration at the triangle of Petite above the iliac crest at mid axillary line 15 mL each.
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Infiltration into the correct plane was confirmed by visualising the 22G needle traversing the extra-peritoneal space without penetration of the parietal peritoneum (Figure 2A). The needle
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was then withdrawn 0.5 mm and infiltration was commenced. Confirmation of the corrected plan was highlighted by the presence of Doyle’s bulge which is covered by the fibers of the thin transversus abdominis muscle (Figure 2B). This process was repeated at the other three points mentioned earlier.
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After TAP Block insertion, peri-portal infiltration was performed by injecting 3, 3, and 7mls, at the planned incision sites of the 5, 5, and 10mm ports respectively. Once port insertion was completed, 10mls of Bupivacaine was dispensed onto the gallbladder and sub-hepatic space
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prior to dissection. Both anaesthesic and surgical times were documented, as well as peri-
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operative analgesic use and blood loss. Pain scores were recorded at 1 hour after surgery using a numerical rating scale from 0-10 (NRS). Once on the surgical ward, patients were commenced on a standardized post-operative analgesic regimen comprising 1g of paracetamol 6 hourly with a stat dose of 75mg Diclofenac Sodium at 12 hours post op. Additional rescue analgesia required in the post-operative setting was recorded by the dispensing nurse.
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Pain scores were recorded at 3, 6, 12, and 24 hours post-operatively with the patient at rest and during coughing. In addition to the presence of nausea, vomiting and/or shoulder tip pain were documented throughout patient stay. Ethical approval was obtained from the Mayo General Hospital research ethics committee (Ref MGH/CR/145-13). This randomised control
(ISRCTN) - Trial registration number - ISRCTN46581210.
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study was registered with The International Standard Randomised Controlled Trial Number
Data was collected and analysed using GraphPad Prism V.5. Analysis of Variance (ANOVA)
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was conducted to examine the difference between group means. A p-value of < 0.05 was considered significant.
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Results Patient characteristics
Eighty patients, (70f, 10m) were enrolled into the study with 40 patients randomised to each group. Age (49.5years vs 52.1years), BMI (29.1 v 31.2), operative and anaesthetic time were
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comparable between both groups (Figure 3 A-D). No adverse events were encountered with the administration of TAP blocks throughout the study. Pain Scores
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Pain scores were collated while patients were at rest and during coughing by using a
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numerical rating scale using a visual aid from 0-10 (NRS) at 1, 3, 6, 12 and 24 hours post laparoscopic cholecystectomy. At 1 hour there was a statistically significant reduction in pain scores both at rest and coughing in patients receiving laparoscopic assisted TAP blocks versus peri-portal local anaesthetic (p=0.018, 0.023, Figure 4 A-B). At 3 and 6 hours post laparoscopic cholecystectomy pain scores at rest and coughing were significantly less in patients receiving laparoscopic assisted TAP blocks compared to conventional peri-portal local anaesthetic infiltration (p=0.024, 0.024, p=0.006, 0.029, Figure 5 A-D).
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ACCEPTED MANUSCRIPT At 12 and 24 hours post laparoscopic cholecystectomy pain scores using a numerical rating system at rest and coughing were not found to be significantly less in patients receiving
laparoscopic assisted TAP blocks versus conventional peri-portal local anaesthetic infiltration (p=0.15, 0.3, p=0.069, 0.108, Figure 6 A-D).
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Secondary endpoints
The amount of post-operative rescue analgesia required by patients while as an inpatient was analysed throughout the study period. It was observed that less oxycodone was required in
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the laparoscopic assisted TAP Block group compared to the control group however this failed
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to reach statistical significance (p=0.12, add mg oxycodone, Figure 7).
On analysis of secondary endpoints, it was observed that the laparoscopic assisted TAP block group had a significantly less amount of post-operative nausea compared to peri-portal analgesia (p<0.046, Figure 8A). Furthermore laparoscopic assisted TAP block did not prolong patient discharge compared to conventional peri-portal local anaesthetic (p=0.13).
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There was no difference noted in the post laparoscopy shoulder tip pain as this is commonly secondary to visceral pain rather than TAP block treated parietal pain. Finally patient
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satisfaction in post-operative analgesic care was highest in the laparoscopic assisted TAP block group however this failed to reach significance (p=0.053 Figure 8B).
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DISCUSSION
In this study we have demonstrated that laparoscopic assisted TAP blocks are superior to conventional peri-portal local anaesthetic infiltration in controlling pain following elective laparoscopic cholecystectomy. In the last decade, TAP blocks have been described as an effective component of multimodal analgesia in the post-operative setting for a wide variety of abdominal procedures (7-13). To date the delivery of TAP blocks has evolved from a blind delivery technique to a partially visualised technique using adjuncts such as an ultrasound machine or laparoscopic camera. Throughout the literature the efficacy of TAP blocks has
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ACCEPTED MANUSCRIPT been demonstrated by reduction in pain scores, reduction of postoperative opioid
requirement, and/or reduction in opioid-related side effects (14-16). In this current study we have demonstrated a statistically significant reduction in post-operative pain scores at 1, 3, and 6 hours while at rest and during coughing. This significant difference was not sustained
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at 12 or 24 hours post surgery and is likely due to the fact that the half life of bupivacaine ranges from 4 to 8 hours. A recent meta-analysis performed comprising of 7 studies (180 cases and 184 controls) demonstrated an average reduction in 24-hour morphine consumption
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of 22 mg in favour of TAP block patients when compared with standard analgesic management (17). Furthermore, TAP blocks were associated with reduced early
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postoperative visual analogue scores (VAS) both at rest and during mobilization in 4 of the 7 studies (1 study did not record VAS scores). Within the meta-analysis, postoperative nausea and vomiting was marginally reduced in patients with TAP blocks. However in this study it was observed the patients within the TAP group had significantly less post-operative nausea
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compared to the control group. It was felt that this was secondary due to reduced postoperative opioid consumption in the TAP group. This positive benefit of reduced opioid requirement in the TAP group has also been highlighted in previous studies however the
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reduction in post-operative nausea scores was not appreciated (18, 19).
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In his original description, Rafi described the use of 20 mL of “a local anaesthetic agent” for each side requiring analgesia (1). Subsequently, McDonnell et al. reported the use of 20 mL of 0.5% lidocaine for each side in patients undergoing surgical procedures (20). Within our study a four point laparoscopic TAP block was performed utilising 25mls of 0.25% bupivacaine for each side. This resulted in a patient receiving an aggregate amount of 125mg of bupivacaine. In contrast, a patient undergoing peri-portal infiltration with local anaesthetic received an aggregate amount of 100mg of bupivacaine. The volume and dosage of bupivacaine selected for patients undergoing peri-portal infiltration with local anaesthetic
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ACCEPTED MANUSCRIPT (20mls of 0.5% solution) was specifically chosen to replicate established clinical practice. The nature of the four quadrant TAP block lends itself to increased volumes of local
anaesthesia as the fluid injected under direct vision traverses the fascial planes. In addition, the laparoscopic-assisted TAP block technique ensures a superior method of post-operative
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analgesia as the somatic nerve supply to the anterior abdominal wall layers is anesthetized for each quadrant.
Injection of additional volumes of local anesthetic agent above a standard volume of 20mls of
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a 0.5% solution may infiltrate the surrounding subcutaneous tissue at the port sites without any additional analgesic effect.
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To date the local anaesthetic agent, volumes, concentration, and delivery method differ between studies and therefore these regimens have not yet been compared against each other. Certain studies, although limited, supports using a continuous TAP block catheter delivery system rather than a single bolus infiltration as in this study (21, 22). A continuous
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catheter delivery system was not used in this study as the patients were discharged within a 24 hour period. Furthermore as documented in the literature it was anticipated that a delivery system left in-situ for greater than 24 hours may lead to increased infections rates (23, 24).
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Complications of TAP block insertion are rare. There were no complications encountered
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with the installation of laparoscopic TAP blocks during the study period. Moreover, all patients underwent a successful insertion of the four point TAP block regardless of patient body habitus, age or co-morbidity. The average length of time for a four point TAP block insertion ranged from 4-7 minutes throughout the study. Within the literature there have been documented case reports of liver lacerations caused by right-sided TAP blocks (25). Upon laparotomy, the patient was subsequently found to have an enlarged liver that extended well below the subcostal margin. As a consequence, the authors recommended routine palpation of the liver edge prior to landmark-based right-sided TAP blocks. A further liver laceration
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ACCEPTED MANUSCRIPT after ultrasound-guided TAP block has been documented in the literature (26). The authors state that it was likely as a result of failure to adequately visualise the needle during the procedure despite the use of an ultrasound machine. These complications highlight an evident risk to other surrounding structures such as the spleen, kidneys and colon. These
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complications are not encountered at laparoscopic assisted TAP block as the needle is directly visualised as it enters into the pre-peritoneal space at laparoscopy.
A recent study analysing the role of TAP blocks in patients undergoing colonic
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resection surgery documented a reduction in the use of post-operative morphine and higher patient satisfaction. Similar findings were observed in this current study. Patient satisfaction
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was higher amongst patients receiving TAP blocks compared to conventional peri-portal infiltration. Although patients within the TAP block group required less post-operative rescue opioid analgesia, this was not found to be significantly less compared to the control group at statistical analysis. The benefits of TAP blocks have also been highlighted in gynaecological
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studies when TAP blocks are used in conjunction with spinal blocks for elective caesarean section (27). A significant reduction in 24-hour morphine requirement was documented in the local anaesthetic TAP block group versus controls (26 mg ±5 mg versus 63 mg ±5 mg).
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Furthermore the authors report lower post-operative nausea, lower 24-hour VAS scores, and
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higher satisfaction in the local anaesthetic TAP block group. Further benefits of laparoscopic assisted TAP blocks have been outlined in a recent study of patients undergoing laparoscopic colonic resection (28). Patients receiving TAP blocks were discharged home earlier compared to the control group. Within our cohort of patients almost 80% of patients were discharged home within 24 hours of admission. Approximately 45% of patients within each group complained of shoulder tip pain. It is currently well understood that this is secondary to phrenic nerve irritation and is not altered by the insertion of TAP blocks or peri-portal infiltration.
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ACCEPTED MANUSCRIPT Although identifying an optimal drug regimen (single bolus infiltration versus indwelling catheter) is clearly an area requiring future investigation, TAP blocks have been shown to be an effective part of post-operative analgesia. Moreover, despite considerable debate over which type of TAP block provides the best coverage for specific surgeries, it is
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our experience that a four quadrant subcostal block is best suited for upper abdominal
procedures. As this procedure becomes standard of care and forms an integral part of the intra-operative procedural pathway for patients undergoing laparoscopic cholecystectomy,
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this should be carried out by all surgeons and thus billed separately as a defined procedure for controlling post-operative pain. Finally further well-designed and adequately powered studies
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are needed to address additional clinically relevant questions such as the use of TAP blocks in the emergency setting. CONCLUSIONS
Laparoscopic TAP Block is an effective and safe adjunct to multimodal postoperative
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analgesia that can be performed by the operating surgeon without the need for additional radiological equipment or specialised skills. The analysis of postoperative pain scores has confirmed the therapeutic benefit of laparoscopically delivered TAP block in elective
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laparoscopic cholecystectomy. This has facilitated a policy of ambulatory elective
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laparoscopic cholecystectomy in our unit. Further studies however are required to evaluate the benefit of laparoscopic assisted TAP blocks in other procedures in both the elective and emergency setting.
Acknowledgment: The authors would like to thank the nursing and theatre staff at Mayo General Hospital.
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Intervention
Test Group
Control Group
50 mL
50 mL
(15+15+10+10) of
(15+15+10+10) of
0.25% Bupivacaine
Normal Saline
20 mL (7+7+3+3) of
20 mL (7+7+3+3)
Normal Saline
of 0.5%
TAP
Peri-portal
Bupivacaine 10 mL of 0.25%
Bupivacaine
Bupivacaine
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10 mL of 0.25%
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Intra-peritoneal
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Table 1: After Randomization Patients Were Assigned into Each Group and Received the Intervention.
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ACCEPTED MANUSCRIPT Figure Legends Figure 1. Study flow diagram. TAP, transversus abdominis plane. Figure 2. At laparoscopy (A) the 22G needle can be visualized traversing into the extra-
peritoneal space. At infiltration of bupivacaine (B) the formation of Doyle’s bulge confirms
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the correction plane of infiltration.
Figure 3. (A) Patient age and (B) body mass index were statistically comparable between the two study groups (p=0.45, 0.14 respectively). There was no statistical difference in (C)
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anaesthetic and (D) surgical time between the two groups (92.4mins v 98.3mins p=0.12, 71.2mins v 73.7mins p=0.34) respectively. TAP, transversus abdominis plane.
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Figure 4. At 1 hour, pain scores (A) at rest and (B) coughing were significantly less in patients receiving laparoscopic assisted transversus abdominis plane blocks versus peri-portal local anaesthetic infiltration (p=0.018, 0.023). NRS, Numerical Rating Score; TAP, transversus abdominis plane.
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Figure 5. At 3 hours at (A) rest and (B) coughing, and at 6 hours at (C) rest and (D) coughing, pain scores at rest and coughing were significantly less in patients receiving
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laparoscopic assisted transversus abdominis plane blocks versus peri-portal local anaesthetic infiltration (p=0.024, 0.024, p=0.006, 0.029). NRS, Numerical Rating Score.
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Figure 6. At 12 hours at (A) rest and (B) coughing, and at 24 hours at (C) rest and (D) coughing, pain scores at rest and coughing were not found to be significantly less in patients receiving laparoscopic assisted transversus abdominis plane blocks versus peri-portal local anaesthetic infiltration (p=0.15, 0.3, p=0.069, 0.108). NRS, Numerical Rating Score; TAP, transversus abdominis plane.
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ACCEPTED MANUSCRIPT Figure 7. Patients receiving laparoscopic assisted transversus abdominis plane blocks required less oxycodone as rescue analgesia in the post-operative setting compared to the control group; however, this failed to reach statistical significance (p=0.12).
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Figure 8. (A) There was a significant reduction in post-operative nausea in patients receiving lap-assisted TAP blocks. Laparoscopic transversus abdominis plane blocks did not defer patent discharge or reduce shoulder tip pain compared to control group. (B) Patient
satisfaction was higher among patients receiving transversus abdominis plane blocks
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(p=0.053). TAP, transversus abdominis plane.
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compared to peri-portal local anaesthesia however this did not reach statistical significance
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ACCEPTED MANUSCRIPT Précis Laparoscopic transversus abdominis plane block is an effective and safe adjunct to multimodal postoperative analgesia that can be performed by the operating surgeon. The analysis of postoperative pain scores has confirmed the therapeutic benefit of
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laparoscopically delivered transversus abdominis plane block in elective laparoscopic
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cholecystectomy.
Efficacy of a laparoscopically delivered Transversus Abdominis Plane block technique during elective laparoscopic cholecystectomy; a prospective double blind randomised trial.
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Enrollment
Assessed for eligibility (n=100)
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Excluded (n=9) Not meeting inclusion criteria (n= 7) Declined to participate (n=2)
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Randomized (n= 91)
Allocation not receive allocated intervention (n= 0)
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Did
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Allocated to peri-portal infiltration (n=44) Received allocated intervention (n=44)
Allocated toTAP Block (n=47) Received allocated intervention (n=47) Did
not receive allocated intervention (n=0)
Follow‐Up
No pain score recorded by night staff (n=3) Unable to record pain score due to PCA (n=1) Discontinued due to drain insertion/additional surgery (n=0)
No pain score recorded by night staff (n=3) Unable to record pain score due to PCA (n= 2) Discontinued due to drain insertion/additional surgery (n=2)
Analysis Analyzed (n= 40)
Analyzed (n= 40)
Figure 1
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A (a) Needle tip seen at extra-peritoneal space
B (b) Doyle’s bulge (confirms L.A. infiltration in TAP)
Figure 2a, b
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Type of Block
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Type of Block
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Figure 4
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Figure 5
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S1072-7515(15)00235-5
DOI:
10.1016/j.jamcollsurg.2015.03.030
Reference:
ACS 7852
To appear in:
Journal of the American College of Surgeons
Received Date: 8 January 2015 Revised Date:
1 March 2015
Accepted Date: 3 March 2015
Please cite this article as: Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ, Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial, Journal of the American College of Surgeons (2015), doi: 10.1016/j.jamcollsurg.2015.03.030. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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ACCEPTED MANUSCRIPT Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block
Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial
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Ghassan Elamin, MRCSI(1), Peadar S Waters, MD(1), Hytham Hamid, MRCSI(1), Hannah M. O'Keeffe, MB, BCH BAO(1); Ronan M Waldron, MB, BCH BAO(1), Michelle Duggan, FRCA (2); Waqar Khan, FRCSI(1), Michael Kevin Barry, MBBCh, FRCSI, FACS(1)(3);
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Iqbal Z Khan, FRCSI(1)
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1. Department of Surgery, Mayo General Hospital, Castlebar, Mayo, Ireland. 2. Discipline of Anaesthesia, Mayo General Hospital, Castlebar, Mayo, Ireland. 3. Professor of Surgery, National University of Ireland Galway
Peadar S Waters, MD,
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Correspondence address:
Department of Surgery, Mayo General Hospital, Castlebar, Mayo, Ireland.
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[email protected]
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Phone: 00353949021733
Disclosure Information: Nothing to disclose. Trial registration number: ISRCTN46581210.
Abstract presented at the American College of Surgeons 100th Annual Clinical Congress, San Francisco, CA, October 2014.
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Short title: Transversus Abdominis Plane Block Technique
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ACCEPTED MANUSCRIPT Background: The management of post-operative pain is paramount in order to facilitate the delivery of day case surgical programmes. In recent years, the complexity of procedures
carried out has increased to include laparoscopic cholecystectomy (LC). The aim of this study is to evaluate the impact of laparoscopic-assisted four-quadrant transversus abdominis plane
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(TAP) block versus peri-portal local anaesthetic wound infiltration in managing postoperative pain.
Study Design: A prospective, randomized, double-blinded trial was performed on patients
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undergoing elective LC. Patients were randomised using computerised “random number
table” into a Test group which received laparoscopic-assisted TAP block with bupivacaine
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with peri-portal saline injection and a Control group which received a laparoscopic-assisted TAP block with saline and peri-portal bupivacaine. All patients received intra-peritoneal instillation of Bupivacaine in the gallbladder bed. Postoperative pain scores were recorded using Numerical Rating Scores (NRS) at rest and coughing at dedicated time points.
significant.
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Statistical analysis was carried out using GraphPad PrismV.5 with p<0.05 considered
Results: Eighty patients, (70f, 10m) were enrolled with 40 patients randomised to each
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group. Age, ASA score, operative time and BMI were comparable between both groups. No
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adverse events were encountered with the administration of TAP blocks. NRS were significantly reduced in the Test group at 1, 3 and 6 hours at rest (p=0.025, 0.03, 0.007) respectively.NRS was significantly reduced at 1, 3 and 6 hours during coughing (p=0.026, 0.02, 0.03) respectively. Difference in post-operative analgesic requirements between both groups was statistically insignificant (p=0.17). Conclusions: This analysis has confirmed the therapeutic benefit of laparoscopically delivered TAP blocks in elective LC.
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ACCEPTED MANUSCRIPT Effective analgesia is an essential part of postoperative management. Adequate pain control is crucial as it enhances early recovery and facilitates the discharge of a satisfied patient. Furthermore it enables early patient mobilisation and prevents post-operative complications such as deep vein thrombosis, pulmonary embolus, pulmonary atelectasis and constipation.
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Local anaesthesia (LA) has been and is still widely considered an important component of the multi-modal analgesic ladder used to achieve optimum pain control following abdominal surgery. Transversus Abdominis Plane block technique (TAP Block) is one such intervention
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in which the local anaesthetic is infiltrated in the fascial plane between the internal oblique and Transversus abdominis muscles where the somatic nerves from T6 to L1 run to innervate
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the anterior abdominal wall layers from the skin to the parietal peritoneum. First described in 2001, a blind “double pop” technique of infiltration was employed to deliver LA into the appropriate site1. The effectiveness of this blind technique is dependent on the administrator noting the pops while the needle traverses the outer two muscles before
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reaching the correct plane. Due to its blind nature and the fact that outcome was heavily reliant on operator competence, further adjuncts were sought to improve accurate delivery of LA into the appropriate plane. The use of an ultrasound guided technique of administration
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was introduced in 2007 which provided the operator with a clear visualisation of the fascial
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planes and needle upon penetration of the individual layers2. In current practice both techniques are commonly carried out by senior anaesthetists with the necessary specialised skill set in regional anaesthesia and ultrasound machine use. The process of delivering a more accurate TAP block by using a laparoscopic assisted technique was investigated in 2011 while carrying out laparoscopic nephrectomies3. The authors confirmed infiltration into the correct plane by visualising the formation of Doyle’s bulge utilizing the presence of the laparoscope camera within the peritoneal cavity. This technique prevented intra-peritoneal
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ACCEPTED MANUSCRIPT infiltration of the LA and proved to be faster and eliminated the need for a specialised skill set and an ultrasound machine. To date there are limited studies analysing the benefit of TAP blocks in laparoscopic cholecystectomy. Results of such limited studies have been conflicting when comparing
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ultrasound guided TAP blocks to conventional peri-portal infiltration for post-operative pain control 4- 6. Currently there are no trials in the literature examining the role of
laparoscopically assisted TAP blocks for the management of peri-operative pain in
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laparoscopic cholecystectomy. With this in mind, the aim of this study was to investigate the benefit of four point laparoscopic assisted TAP blocks compared to conventional and widely
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used peri-portal infiltration of local anaesthesia in patients undergoing elective laparoscopic cholecystectomy. METHODS
This study was conducted in the Department of General surgery at Mayo General Hospital,
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Ireland from May 2013 to March 2014. Mayo General Hospital is a teaching hospital affiliated to the National University of Ireland Galway. Sample size was calculated; 16 patients were required in each arm to reach power of 80%. Reevaluation was performed at 30
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(Figure 1).
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and to avoid type II error, sample size was expanded to 80 with 40 patients in each arm
Inclusion criteria
All consecutive ASA grade I-II patients undergoing elective laparoscopic cholecystectomy between the ages of 18 to 85 years. Exclusion criteria •
Emergency laparoscopic cholecystectomy.
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ASA grade III, IV, V
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Conversion to open procedures.
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ACCEPTED MANUSCRIPT Coagulopathy.
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Significant liver or renal disease.
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Allergy to Bupivacaine.
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Diagnosis of chronic pain syndrome.
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Known alcohol or substance abuse within the last 6 months.
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Daily Opioid intake.
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Abdominal drain use.
Test group - received laparoscopic assisted TAP block with bupivacaine and periportal sterile saline.
•
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•
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The patients were randomized into two groups:
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•
Control group - received laparoscopic assisted TAP block with sterile saline and periportal infiltration of bupivacaine.
Using a computerised “random number table” technique, a randomisation list was generated
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and patients were allocated following the list order on the day of admission. The procedure and intervention was explained to each patient by the admitting doctor and informed consent obtained prior to transfer to theatre.
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Prior to randomisation three syringes sets were prepared (Table 1):
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1. 15mls syringes X 2 + 10 mL syringes X 2 for infiltration of the four point TAP Block. 2. 20 ml syringe X 1 for peri-portal infiltration. 3. 10 mL syringe for gall bladder bed infiltration. Both the operating and the anaesthetic teams were blind to the intervention received by the patient. After randomisation, patients were assigned into each group to receive:Intervention After induction of anaesthesia, 7mls of the 20mls syringe was infiltrated into the umbilical port site just before making the skin incision. Following the insertion of this port a pneumo-
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ACCEPTED MANUSCRIPT peritonium was created with pressure standardized to 12MMHg for all patients. At this point with the aid of direct visualisation of peritoneum with the laparoscope, Tap Blocks were instilled using a 22G needle at four points as follows: •
Bilateral subcostal infiltration between anterior axillary and mid clavicular lines - 10
•
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mL each.
Bilateral infiltration at the triangle of Petite above the iliac crest at mid axillary line 15 mL each.
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Infiltration into the correct plane was confirmed by visualising the 22G needle traversing the extra-peritoneal space without penetration of the parietal peritoneum (Figure 2A). The needle
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was then withdrawn 0.5 mm and infiltration was commenced. Confirmation of the corrected plan was highlighted by the presence of Doyle’s bulge which is covered by the fibers of the thin transversus abdominis muscle (Figure 2B). This process was repeated at the other three points mentioned earlier.
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After TAP Block insertion, peri-portal infiltration was performed by injecting 3, 3, and 7mls, at the planned incision sites of the 5, 5, and 10mm ports respectively. Once port insertion was completed, 10mls of Bupivacaine was dispensed onto the gallbladder and sub-hepatic space
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prior to dissection. Both anaesthesic and surgical times were documented, as well as peri-
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operative analgesic use and blood loss. Pain scores were recorded at 1 hour after surgery using a numerical rating scale from 0-10 (NRS). Once on the surgical ward, patients were commenced on a standardized post-operative analgesic regimen comprising 1g of paracetamol 6 hourly with a stat dose of 75mg Diclofenac Sodium at 12 hours post op. Additional rescue analgesia required in the post-operative setting was recorded by the dispensing nurse.
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Pain scores were recorded at 3, 6, 12, and 24 hours post-operatively with the patient at rest and during coughing. In addition to the presence of nausea, vomiting and/or shoulder tip pain were documented throughout patient stay. Ethical approval was obtained from the Mayo General Hospital research ethics committee (Ref MGH/CR/145-13). This randomised control
(ISRCTN) - Trial registration number - ISRCTN46581210.
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study was registered with The International Standard Randomised Controlled Trial Number
Data was collected and analysed using GraphPad Prism V.5. Analysis of Variance (ANOVA)
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was conducted to examine the difference between group means. A p-value of < 0.05 was considered significant.
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Results Patient characteristics
Eighty patients, (70f, 10m) were enrolled into the study with 40 patients randomised to each group. Age (49.5years vs 52.1years), BMI (29.1 v 31.2), operative and anaesthetic time were
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comparable between both groups (Figure 3 A-D). No adverse events were encountered with the administration of TAP blocks throughout the study. Pain Scores
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Pain scores were collated while patients were at rest and during coughing by using a
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numerical rating scale using a visual aid from 0-10 (NRS) at 1, 3, 6, 12 and 24 hours post laparoscopic cholecystectomy. At 1 hour there was a statistically significant reduction in pain scores both at rest and coughing in patients receiving laparoscopic assisted TAP blocks versus peri-portal local anaesthetic (p=0.018, 0.023, Figure 4 A-B). At 3 and 6 hours post laparoscopic cholecystectomy pain scores at rest and coughing were significantly less in patients receiving laparoscopic assisted TAP blocks compared to conventional peri-portal local anaesthetic infiltration (p=0.024, 0.024, p=0.006, 0.029, Figure 5 A-D).
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ACCEPTED MANUSCRIPT At 12 and 24 hours post laparoscopic cholecystectomy pain scores using a numerical rating system at rest and coughing were not found to be significantly less in patients receiving
laparoscopic assisted TAP blocks versus conventional peri-portal local anaesthetic infiltration (p=0.15, 0.3, p=0.069, 0.108, Figure 6 A-D).
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Secondary endpoints
The amount of post-operative rescue analgesia required by patients while as an inpatient was analysed throughout the study period. It was observed that less oxycodone was required in
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the laparoscopic assisted TAP Block group compared to the control group however this failed
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to reach statistical significance (p=0.12, add mg oxycodone, Figure 7).
On analysis of secondary endpoints, it was observed that the laparoscopic assisted TAP block group had a significantly less amount of post-operative nausea compared to peri-portal analgesia (p<0.046, Figure 8A). Furthermore laparoscopic assisted TAP block did not prolong patient discharge compared to conventional peri-portal local anaesthetic (p=0.13).
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There was no difference noted in the post laparoscopy shoulder tip pain as this is commonly secondary to visceral pain rather than TAP block treated parietal pain. Finally patient
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satisfaction in post-operative analgesic care was highest in the laparoscopic assisted TAP block group however this failed to reach significance (p=0.053 Figure 8B).
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DISCUSSION
In this study we have demonstrated that laparoscopic assisted TAP blocks are superior to conventional peri-portal local anaesthetic infiltration in controlling pain following elective laparoscopic cholecystectomy. In the last decade, TAP blocks have been described as an effective component of multimodal analgesia in the post-operative setting for a wide variety of abdominal procedures (7-13). To date the delivery of TAP blocks has evolved from a blind delivery technique to a partially visualised technique using adjuncts such as an ultrasound machine or laparoscopic camera. Throughout the literature the efficacy of TAP blocks has
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ACCEPTED MANUSCRIPT been demonstrated by reduction in pain scores, reduction of postoperative opioid
requirement, and/or reduction in opioid-related side effects (14-16). In this current study we have demonstrated a statistically significant reduction in post-operative pain scores at 1, 3, and 6 hours while at rest and during coughing. This significant difference was not sustained
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at 12 or 24 hours post surgery and is likely due to the fact that the half life of bupivacaine ranges from 4 to 8 hours. A recent meta-analysis performed comprising of 7 studies (180 cases and 184 controls) demonstrated an average reduction in 24-hour morphine consumption
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of 22 mg in favour of TAP block patients when compared with standard analgesic management (17). Furthermore, TAP blocks were associated with reduced early
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postoperative visual analogue scores (VAS) both at rest and during mobilization in 4 of the 7 studies (1 study did not record VAS scores). Within the meta-analysis, postoperative nausea and vomiting was marginally reduced in patients with TAP blocks. However in this study it was observed the patients within the TAP group had significantly less post-operative nausea
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compared to the control group. It was felt that this was secondary due to reduced postoperative opioid consumption in the TAP group. This positive benefit of reduced opioid requirement in the TAP group has also been highlighted in previous studies however the
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reduction in post-operative nausea scores was not appreciated (18, 19).
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In his original description, Rafi described the use of 20 mL of “a local anaesthetic agent” for each side requiring analgesia (1). Subsequently, McDonnell et al. reported the use of 20 mL of 0.5% lidocaine for each side in patients undergoing surgical procedures (20). Within our study a four point laparoscopic TAP block was performed utilising 25mls of 0.25% bupivacaine for each side. This resulted in a patient receiving an aggregate amount of 125mg of bupivacaine. In contrast, a patient undergoing peri-portal infiltration with local anaesthetic received an aggregate amount of 100mg of bupivacaine. The volume and dosage of bupivacaine selected for patients undergoing peri-portal infiltration with local anaesthetic
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ACCEPTED MANUSCRIPT (20mls of 0.5% solution) was specifically chosen to replicate established clinical practice. The nature of the four quadrant TAP block lends itself to increased volumes of local
anaesthesia as the fluid injected under direct vision traverses the fascial planes. In addition, the laparoscopic-assisted TAP block technique ensures a superior method of post-operative
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analgesia as the somatic nerve supply to the anterior abdominal wall layers is anesthetized for each quadrant.
Injection of additional volumes of local anesthetic agent above a standard volume of 20mls of
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a 0.5% solution may infiltrate the surrounding subcutaneous tissue at the port sites without any additional analgesic effect.
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To date the local anaesthetic agent, volumes, concentration, and delivery method differ between studies and therefore these regimens have not yet been compared against each other. Certain studies, although limited, supports using a continuous TAP block catheter delivery system rather than a single bolus infiltration as in this study (21, 22). A continuous
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catheter delivery system was not used in this study as the patients were discharged within a 24 hour period. Furthermore as documented in the literature it was anticipated that a delivery system left in-situ for greater than 24 hours may lead to increased infections rates (23, 24).
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Complications of TAP block insertion are rare. There were no complications encountered
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with the installation of laparoscopic TAP blocks during the study period. Moreover, all patients underwent a successful insertion of the four point TAP block regardless of patient body habitus, age or co-morbidity. The average length of time for a four point TAP block insertion ranged from 4-7 minutes throughout the study. Within the literature there have been documented case reports of liver lacerations caused by right-sided TAP blocks (25). Upon laparotomy, the patient was subsequently found to have an enlarged liver that extended well below the subcostal margin. As a consequence, the authors recommended routine palpation of the liver edge prior to landmark-based right-sided TAP blocks. A further liver laceration
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complications are not encountered at laparoscopic assisted TAP block as the needle is directly visualised as it enters into the pre-peritoneal space at laparoscopy.
A recent study analysing the role of TAP blocks in patients undergoing colonic
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resection surgery documented a reduction in the use of post-operative morphine and higher patient satisfaction. Similar findings were observed in this current study. Patient satisfaction
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was higher amongst patients receiving TAP blocks compared to conventional peri-portal infiltration. Although patients within the TAP block group required less post-operative rescue opioid analgesia, this was not found to be significantly less compared to the control group at statistical analysis. The benefits of TAP blocks have also been highlighted in gynaecological
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studies when TAP blocks are used in conjunction with spinal blocks for elective caesarean section (27). A significant reduction in 24-hour morphine requirement was documented in the local anaesthetic TAP block group versus controls (26 mg ±5 mg versus 63 mg ±5 mg).
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Furthermore the authors report lower post-operative nausea, lower 24-hour VAS scores, and
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higher satisfaction in the local anaesthetic TAP block group. Further benefits of laparoscopic assisted TAP blocks have been outlined in a recent study of patients undergoing laparoscopic colonic resection (28). Patients receiving TAP blocks were discharged home earlier compared to the control group. Within our cohort of patients almost 80% of patients were discharged home within 24 hours of admission. Approximately 45% of patients within each group complained of shoulder tip pain. It is currently well understood that this is secondary to phrenic nerve irritation and is not altered by the insertion of TAP blocks or peri-portal infiltration.
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ACCEPTED MANUSCRIPT Although identifying an optimal drug regimen (single bolus infiltration versus indwelling catheter) is clearly an area requiring future investigation, TAP blocks have been shown to be an effective part of post-operative analgesia. Moreover, despite considerable debate over which type of TAP block provides the best coverage for specific surgeries, it is
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our experience that a four quadrant subcostal block is best suited for upper abdominal
procedures. As this procedure becomes standard of care and forms an integral part of the intra-operative procedural pathway for patients undergoing laparoscopic cholecystectomy,
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this should be carried out by all surgeons and thus billed separately as a defined procedure for controlling post-operative pain. Finally further well-designed and adequately powered studies
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are needed to address additional clinically relevant questions such as the use of TAP blocks in the emergency setting. CONCLUSIONS
Laparoscopic TAP Block is an effective and safe adjunct to multimodal postoperative
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analgesia that can be performed by the operating surgeon without the need for additional radiological equipment or specialised skills. The analysis of postoperative pain scores has confirmed the therapeutic benefit of laparoscopically delivered TAP block in elective
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laparoscopic cholecystectomy. This has facilitated a policy of ambulatory elective
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laparoscopic cholecystectomy in our unit. Further studies however are required to evaluate the benefit of laparoscopic assisted TAP blocks in other procedures in both the elective and emergency setting.
Acknowledgment: The authors would like to thank the nursing and theatre staff at Mayo General Hospital.
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Neuburger M, Buttner J, Blumenthal S, et al. Inflammation and infection
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Farooq M, Carey M. A case of liver trauma with a blunt regional anesthesia needle
while performing transversus abdominis plane block. Regional Anesthesia and Pain Medicine 2008;33:274–275. Lancaster P, Chadwick M, “Liver trauma secondary to ultrasound-guided transversus
abdominis plane block. Br J Anaesth 2010;104:509–510. 27.
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26.
Baaj JM, Alsatli RA, Majaj HA, et al. Efficacy of ultrasound-guided transversus
abdominis plane (TAP) block for post-cesarean section delivery analgesia—a double-blind,
28.
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placebo-controlled, randomized study. Middle East J Anesthesiol 2010; 20:821–826.
Favuzza J, Delaney CP. Outcomes of Discharge after Elective Laparoscopic
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Colorectal Surgery with Transversus Abdominis Plane Blocks and Enhanced Recovery
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Pathway. J Am Coll Surg. 2013;217:3503–506.
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Intervention
Test Group
Control Group
50 mL
50 mL
(15+15+10+10) of
(15+15+10+10) of
0.25% Bupivacaine
Normal Saline
20 mL (7+7+3+3) of
20 mL (7+7+3+3)
Normal Saline
of 0.5%
TAP
Peri-portal
Bupivacaine 10 mL of 0.25%
Bupivacaine
Bupivacaine
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10 mL of 0.25%
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Intra-peritoneal
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Table 1: After Randomization Patients Were Assigned into Each Group and Received the Intervention.
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ACCEPTED MANUSCRIPT Figure Legends Figure 1. Study flow diagram. TAP, transversus abdominis plane. Figure 2. At laparoscopy (A) the 22G needle can be visualized traversing into the extra-
peritoneal space. At infiltration of bupivacaine (B) the formation of Doyle’s bulge confirms
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the correction plane of infiltration.
Figure 3. (A) Patient age and (B) body mass index were statistically comparable between the two study groups (p=0.45, 0.14 respectively). There was no statistical difference in (C)
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anaesthetic and (D) surgical time between the two groups (92.4mins v 98.3mins p=0.12, 71.2mins v 73.7mins p=0.34) respectively. TAP, transversus abdominis plane.
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Figure 4. At 1 hour, pain scores (A) at rest and (B) coughing were significantly less in patients receiving laparoscopic assisted transversus abdominis plane blocks versus peri-portal local anaesthetic infiltration (p=0.018, 0.023). NRS, Numerical Rating Score; TAP, transversus abdominis plane.
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Figure 5. At 3 hours at (A) rest and (B) coughing, and at 6 hours at (C) rest and (D) coughing, pain scores at rest and coughing were significantly less in patients receiving
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laparoscopic assisted transversus abdominis plane blocks versus peri-portal local anaesthetic infiltration (p=0.024, 0.024, p=0.006, 0.029). NRS, Numerical Rating Score.
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Figure 6. At 12 hours at (A) rest and (B) coughing, and at 24 hours at (C) rest and (D) coughing, pain scores at rest and coughing were not found to be significantly less in patients receiving laparoscopic assisted transversus abdominis plane blocks versus peri-portal local anaesthetic infiltration (p=0.15, 0.3, p=0.069, 0.108). NRS, Numerical Rating Score; TAP, transversus abdominis plane.
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ACCEPTED MANUSCRIPT Figure 7. Patients receiving laparoscopic assisted transversus abdominis plane blocks required less oxycodone as rescue analgesia in the post-operative setting compared to the control group; however, this failed to reach statistical significance (p=0.12).
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Figure 8. (A) There was a significant reduction in post-operative nausea in patients receiving lap-assisted TAP blocks. Laparoscopic transversus abdominis plane blocks did not defer patent discharge or reduce shoulder tip pain compared to control group. (B) Patient
satisfaction was higher among patients receiving transversus abdominis plane blocks
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(p=0.053). TAP, transversus abdominis plane.
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compared to peri-portal local anaesthesia however this did not reach statistical significance
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ACCEPTED MANUSCRIPT Précis Laparoscopic transversus abdominis plane block is an effective and safe adjunct to multimodal postoperative analgesia that can be performed by the operating surgeon. The analysis of postoperative pain scores has confirmed the therapeutic benefit of
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laparoscopically delivered transversus abdominis plane block in elective laparoscopic
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cholecystectomy.
Efficacy of a laparoscopically delivered Transversus Abdominis Plane block technique during elective laparoscopic cholecystectomy; a prospective double blind randomised trial.
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Enrollment
Assessed for eligibility (n=100)
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Excluded (n=9) Not meeting inclusion criteria (n= 7) Declined to participate (n=2)
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Randomized (n= 91)
Allocation not receive allocated intervention (n= 0)
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Allocated to peri-portal infiltration (n=44) Received allocated intervention (n=44)
Allocated toTAP Block (n=47) Received allocated intervention (n=47) Did
not receive allocated intervention (n=0)
Follow‐Up
No pain score recorded by night staff (n=3) Unable to record pain score due to PCA (n=1) Discontinued due to drain insertion/additional surgery (n=0)
No pain score recorded by night staff (n=3) Unable to record pain score due to PCA (n= 2) Discontinued due to drain insertion/additional surgery (n=2)
Analysis Analyzed (n= 40)
Analyzed (n= 40)
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A (a) Needle tip seen at extra-peritoneal space
B (b) Doyle’s bulge (confirms L.A. infiltration in TAP)
Figure 2a, b
B
Type of Block
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Type of Block
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B
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Figure 5
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Figure 6
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Figure 7
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B