Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Post Operative Pain Clinical Trial

Official title:

Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921604
• Other study ID #: 35648
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: Aya gamal moussa, assistant lecturer
• Phone: 01222607803
• Email: ayamoussa47[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Baclofen 10mg
which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia.
• Gabapentin
which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia.

Locations

Country	Name	City	State
Egypt	Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.