Oblique Subcostal Tap Block Efficacy in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable supraumbilical analgesia.

Detailed Description
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Laparoscopic cholecystectomy is a minimally invasive widespread surgical procedure, with postoperative lower pain scores and quick recovery of the patient. However some of patients may complain of considerable pain after surgery . There are several approaches to postoperative pain management after laparoscopic cholecystectomy such as patient-controlled analgesia with opioids (IV-PCA), neuraxial blocks, intraperitoneal injection of local anesthetics, wound infiltration, each being more or less effective, with specific side effects. The transversus abdominis plane block (TAP-Block) is a regional analgesia technique that comes as an alternative to classical procedures of postoperative analgesia. Described by Rafi and McDonnell et al. this technique has undergone some changes over times, which increased its efficiency. Thus, Hebbard et al. described ultrasound subcostal oblique approach (OSTAP) of the block allowing analgesia in both the upper and lower abdomen, with a lower rate of complications due to the direct ultrasound visualization. Different studies confirmed the analgesic efficacy of this technique and the postoperative opioid sparing effect after laparoscopic cholecystectomy . Traditionally, the transversus abdominis plane block is achieved with classical amino-amides local anesthetics, bupivacaine, levobupivacaine and ropivacaine being the most commonly used . Based on the local anesthetic properties of pethidine, a synthetic opioid, our study aimed to evaluate prospectively the analgesic efficacy of pethidine in achieving transversus abdominis plane block by ultrasound oblique subcostal approach in patients scheduled for elective laparoscopic cholecystectomy.

Official Title
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Oblique Subcostal Transverses Abdominal Plane Block in Laparoscopic Cholecystectomy

Conditions
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Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Bupivacaine
* Drug: Pethidine
* Drug: Pethidine Local Infiltration (L.I)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anaesthesiologists (ASA) I-II Age over 18years old patients scheduled elective laparoscopic cholecystectomy Exclusion Criteria: Open cholecystectomy - excluded due to increased levels of pain in open procedures Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection Allergy or contraindication to any of the study medications or anesthetic agents Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder) Pregnancy Prisoners Patient or surgeon refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Oblique subcostal tap block with normal sterile saline ,20 ml, bilateral, single shot,24h | Drug: Placebo<br>* Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side<br>* Other names: Tap Block Placebo;|
| Active Comparator: Bupivacaine<br>Oblique subcostal tap block with bupivacaine 0,25% ,20 ml, bilateral, single shot,24h | Drug: Bupivacaine<br>* Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.<br>* Other names: Tap Block Bupivacaine;|
| Active Comparator: Pethidine<br>Oblique subcostal tap block with pethidine 1% ,10 ml,bilateral,single shot,24h | Drug: Pethidine<br>* Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side<br>* Other names: Tap Block Pethidine;|
| Active Comparator: Pethidine Local Infiltration (L.I.)<br>Local infiltration of pethidine 1% at trocar insertion sites, 5ml /site, 24h compared with Tap Block with pethidine 1% | Drug: Pethidine Local Infiltration (L.I)<br>* Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1%<br>* Other names: Pethidine Local Infiltration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 2 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups. | Recorded 2 hours postoperative | 
| Pain Scores | This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 6 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups. | Recorded 6 hours postoperative | 
| Pain Scores | This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 12 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups. | Recorded 12 hours postoperative | 
| Pain Scores | This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 24 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups. | Recorded 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative fentanyl consumption | Recording total amount of intraoperative fentanyl consumption | 0-4 hours | 
| Time to first opioid administration in Post Anesthetic Care Unit | Recording time to first opioid administration in post aesthetic care unit | 0-4 hours postoperative | 
| Cumulative opioid consumption | Recording total amount of opioids used in postoperative period | Recorded in the first 24 hours perioperative period | 
| Side effects | nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe | Recorded in the first 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pethidine, laparoscopic cholecystectomy, bupivacaine