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NCT Number: NCT05921604

Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt

Tanta, Gharbia Governorate, 31111, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baclofen 10mg

Drug

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

Gabapentin

Drug

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

Primary outcomes

  1. visual analog scale (VAS) score

    Time frame: The first 48 hours after surgery.

    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 outcomes

  1. sedation score

    Time frame: The first 48 hours after surgery.

    Postoperative sedation scores will be evaluated using the following scale: 0 = awake, 1 = mild sedation, 2 = sleepy but arousable, and 3 = very sleepy.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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