Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Phase 3Active Not RecruitingNCT05921604

Tanta University100 enrolled

Overview

The aim of this study is to compare the possible efficacy of baclofen and gabapentin on postoperative pain in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Post Operative Pain

Interventions

Baclofen 10mgDRUG

which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia.

GabapentinDRUG

which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * \- Age between 18-60 years old. * Both male and female patients will be included. * Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes. * Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity. * Patients fit for anesthesia and surgery. Exclusion Criteria: * Patients with BMI \>55 kg/m2. * Patients with previous procedures for the treatment of obesity. * Pregnant females and lactating women. * Patients with psychological or psychiatric disease * Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery * Patients who experienced vomiting within 24 hours before surgery. * Patients with history of alcohol or drug abuse. * Patients with hypersensitivity or contraindications to any of the drugs used in this study.

Locations (1)

Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt

Tanta, Gharbia Governorate, Egypt

Outcomes

Primary Outcomes

visual analog scale (VAS) score

During the first 48-h postoperative study period, patients were asked to rate their intensity of pain using visual analog scale (VAS) scores. the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

Time frame: The first 48 hours after surgery.

Secondary Outcomes

sedation score

Postoperative sedation scores will be evaluated using the following scale: 0 = awake, 1 = mild sedation, 2 = sleepy but arousable, and 3 = very sleepy.

Time frame: The first 48 hours after surgery.

Data from ClinicalTrials.gov

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