Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Tanta University

Status and phase: Active, not recruiting; Phase 3

Conditions: Post Operative Pain

Treatments: Drug: Baclofen 10mg; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT05921604

35648

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Group 1 (baclofen)

Experimental group

Description:

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

Treatment:

Drug: Baclofen 10mg

Group 2 (gabapentin)

Experimental group

Description:

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

Treatment:

Drug: Gabapentin