General Anesthesia vs Paravertebral Block With General Anesthesia For Laparoscopic Sleeve Gastrectomy

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Other: general anesthesia; Other: Placebo PVB; Other: Paravertebral block

• Registration Number: NCT03469700
• Lead Sponsor: Makassed General Hospital

Brief Summary

The incidence of obesity is steadily rising. Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management of morbid obesity.

We will be discussing the effect of adding paravertebral block (PVB) in addition to general anesthesia (GA) vs. GA alone for post operative pain after laparoscopic sleeve gastrectomy.

Detailed Description

This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups: Group 1 will be patients who receive general anesthesia with paravertebral block, whereas group 2 will be patients who receive general anesthesia with placebo block.

Study Timeline

• Study First Submitted: 2018-03-03
• Study Start: 2018-03-15
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-27
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

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

Inclusion Criteria

• Patients with body mass index (BMI) greater than or equal to 30
• American Society of Anesthesiologist (ASA) score greater than or equal to 2
• Undergoing laparoscopic gastric sleeve surgeries

Exclusion Criteria

• Patients with ASA score less than 2 and greater than 4
• Patients with any type of allergy to local anesthesia
• Patients refusing to be part of the study (refusal to sign consent)
• Any complication during surgery or anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GA+placebo PVB	Placebo PVB	Patients will receive general anesthesia with placebo block
GA+PVB	general anesthesia	Patients will receive general anesthesia with paravertebral block
GA+PVB	Paravertebral block	Patients will receive general anesthesia with paravertebral block
GA+placebo PVB	general anesthesia	Patients will receive general anesthesia with placebo block

Primary Outcome Measures

Name	Time	Method
postoperative pain	within 1 week postoperatively	The primary aim is to compare the effect of paravertebral block with general anesthesia versus general anesthesia alone on postoperative pain after laparoscopic sleeve gastrectomy surgeries. Pain will be assessed using the Visual Analogue scale (VAS) with a score of 0 denoting no pain and 10 maximum possible pain.

Secondary Outcome Measures

Name	Time	Method
ambulation	within 1 week postoperatively	The secondary aim is to assess the time of first movement (early ambulation) between both groups. This will be assessed via a questionnaire

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon