The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure.

Study Overview
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Brief Summary
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Sleeve gastrectomy is the most performed bariatric procedure worldwide. Postoperative pain management is a challenging issue. In this trial, the investigators aimed to explore the effects of laparoscopic guided transversus abdominis plane (TAP) block on postoperative pain management in patient those were performed laparoscopic sleeve gastrectomy.

Detailed Description
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TAP block is a regional anesthesia technique which could be performed easily especially by laparoscopy and are used in various surgical procedures. In that technique, blockade of the plane between internal oblique muscle and transversus abdominis muscle is performed by infiltration of local anesthesics drugs. Therefore , reduction of postoperative pain could be lead to decrease in postoperative complications.

Official Title
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The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure: A Randomized Single Blinded Placebo Controlled Trial

Conditions
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Obesity, Morbid, Postoperative Pain, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Procedure: Transversus abdominis plane block
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients between 18-65 undergo Laparoscopic sleeve gastrectomy Exclusion Criteria: Bupivacaine allergy having chronic pain or taking pain management ASA ( The American Society of Anesthesiologists Physical Classification System) Class 4 or Patients who were performed additional procedures including cholecystectomy, hiatal hernia repair or abdominal hernia repair

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Interventional Model Description: Forty patients had divided into two groups; TAP block group (TAP-B) and placebo (P) group. Every group contained 20 patients and randomization was performed by sealed envelope method. Patient and the data collector resident didn't know the which procedure was done thus single-blinded randomization were provided.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP Block<br>In this group ,TAP block will be performed with 0.5% 15 ml bupivacaine + 5 ml . | Procedure: Transversus abdominis plane block<br>* TAP block will be performed by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.<br>|
| Placebo Comparator: Placebo<br>In this group , 20 ml saline solution will injected into the transversus abdominis plane. | Drug: Placebo<br>* 20 ml saline solution will be injected by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale (VAS) scores | VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10 | 24th ours | 
| postoperative analgesia doses | totally consumed analgesics | within 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting score | PONV (Postoperative nausea and vomiting) score calculated with PONV scale: score 0: no nausea or vomiting, score 1:mild nausea, not requesting medication, score 2: moderate nausea requesting medication, score 3: severe nausea and/or vomiting minimum:0 maximum:3 | within 24 hours postoperatively | 
| first mobilization and flatus time | first mobilization and flatus time | within 24 hours postoperatively | 
| time of first opioid administration | time of first opioid administration | within 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeve gastrectomy, Transversus abdominis plane block, Postoperative pain management