Back to resultsBaclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Baclofen 10mg
Gabapentin
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain
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.
Sites / Locations
- Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, EgyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1 (baclofen)
Group 2 (gabapentin)
Arm Description
which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia.
which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05921604
Brief Title
Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy
Official Title
Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (baclofen)
Arm Type
Experimental
Arm Description
which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia.
Arm Title
Group 2 (gabapentin)
Arm Type
Experimental
Arm Description
which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia.
Intervention Type
Drug
Intervention Name(s)
Baclofen 10mg
Intervention Description
which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia.
Primary Outcome Measure Information:
Title
visual analog scale (VAS) score
Description
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 Outcome Measure Information:
Title
sedation score
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya gamal moussa, assistant lecturer
Phone
01222607803
Email
ayamoussa47@yahoo.com
Facility Information:
Facility Name
Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt
City
Tanta
State/Province
Gharbiya
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aya gamal moussa, assistant lecturer
Phone
01222607803
Email
aya.mosa@pharm.tanta.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
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Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy
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