Clinical trial

Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve

Name

35648

Description

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.

Trial arms

Trial start

2023-06-30

Estimated PCD

2024-08-01

Trial end

2024-09-01

Status

Recruiting

Phase

Early phase I

Treatment

Baclofen 10mg

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

Arms:

Group 1 (baclofen)

Gabapentin

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

Arms:

Group 2 (gabapentin)

Size

100

Primary endpoint

visual analog scale (VAS) score

The first 48 hours after surgery.

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-11-22

1 organization

2 products

1 indication

Organization

Product

Indication

Product