Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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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.

Official Title
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Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Baclofen 10mg
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (baclofen)<br>which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia. | Drug: Baclofen 10mg<br>* which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia.<br>|
| Experimental: Group 2 (gabapentin)<br>which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia. | Drug: Gabapentin<br>* which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The first 48 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The first 48 hours after surgery. |