Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy

Phase 2

Completed

• Conditions: Postoperative Complications
• Interventions: Drug: Placebo Oral Capsule; Drug: Gabapentin

• Registration Number: NCT03023501
• Lead Sponsor: King Saud University

Brief Summary

The evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative opioid-sparing properties.This study will highlight the effectiveness of preoperative use of gabapentin for postoperative pain management in morbidly obese patients.

Detailed Description

Research Problem: Laprocopic sleeve gastrectomy is the most common surgical procedure performed for reducing weight in morbidly obese patients. Laparoscopic surgery is considered to be less invasive than open surgery. The treatment of pain in obese patients is a challenge. Administering opioids, can have an increasing effect of respiratory depression in patients already at risk of sleep apnea. The evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative opioid-sparing properties. The analgesic effect of gabapentin appears to be related to the surgical procedure undertaken, a more procedure-specific evaluation is needed for different types of surgeries..

Research Significance: This study will highlight the effectiveness of preoperative use of gabapentin for postoperative pain management in morbidly obese patients.

Research Objectives: To evaluate the effect of preoperative administration of gabapentin on postoperative pain, postoperative morphine consumption and preoperative anxiety in patients coming for laparoscopic sleeve gastrectomy.

Research Methodology:

Inclusion criteria: ASA I and II, Age 18-50 years, either sex, Planned Surgical procedure laparoscopic sleeve garstectomy, BMI 30-45 . Exclusion criteria: Patients taking any sedative, tranquillizers , history of sleep apnoea ,contraindications to gabapentin, Methods Patients will be randomly assigned into two groups, Group-Control and , Group- Gabapentin of 25 each. Anesthesia and postoperative course will be standardized. VAS scale will be used for assessment of preoperative anxiety and postoperative pain. Post operatively pain assessment and morphine consumption will be performed for 24 hours in PACU and ward

Study Timeline

• Study Start: 2014-03
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ASA 1 and 2
• BMI 35 - 45

Exclusion Criteria

• Patients taking any sedative or tranquillizers
• Any contraindication to gabapentin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Capsule	Placebo capsule was prepared by hospital pharmacy and was administered orally 2 hours before surgery.
Gabapentin	Gabapentin	Gabapentin 1200mg capsule was administered orally 2 hours before surgery

Primary Outcome Measures

Name	Time	Method
Post operative pain	4 hourly in the ward for 24 hours
Post operative Morphine requirement	4 hourly in the ward for 24 hours

Secondary Outcome Measures

Name	Time	Method
Preoperative anxiety	30 minutes before surgery