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

Not Applicable

Completed

• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Obesity, Morbid
• Interventions: Drug: Placebo; Procedure: Transversus abdominis plane block

• Registration Number: NCT05447429
• Lead Sponsor: Samsun Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Study First Submitted: 2022-06-25
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-01
• Last Update Submitted: 2022-07-01
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	In this group , 20 ml saline solution will injected into the transversus abdominis plane.
TAP Block	Transversus abdominis plane block	In this group ,TAP block will be performed with 0.5% 15 ml bupivacaine + 5 ml .

Primary Outcome Measures

Name	Time	Method
visual analogue scale (VAS) scores	24th ours	VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10
postoperative analgesia doses	within 24 hours postoperatively	totally consumed analgesics

Secondary Outcome Measures

Name	Time	Method
Nausea and vomiting score	within 24 hours postoperatively	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
first mobilization and flatus time	within 24 hours postoperatively	first mobilization and flatus time
time of first opioid administration	within 24 hours postoperatively	time of first opioid administration

Trial Locations

Locations (1)

Samsun Research and Training Hospital; 🇹🇷 Samsun, Turkey