Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy

Postoperative Complications Clinical Trial

Official title:

The Effect of Gabapentin on Postoperataive Pain ,Morphine Sparing Effect and Preoperative Anxiety in Bariatric Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023501
• Other study ID #: E-13-902
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2017
• Last updated: January 13, 2017
• Start date: March 2014
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• ASA 1 and 2

• BMI 35 - 45

Exclusion Criteria:

• Patients taking any sedative or tranquillizers

• Any contraindication to gabapentin.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Drug:
• Gabapentin

• Placebo Oral Capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative Morphine requirement		At 2 hours in Post Anesthesia Care Unit
Primary	Post operative pain		At 2 hours in Post Anesthesia Care Unit
Primary	Post operative Morphine requirement		4 hourly in the ward for 24 hours
Primary	Post operative pain		4 hourly in the ward for 24 hours
Secondary	Preoperative anxiety		30 minutes before surgery