Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy

King Saud University

Status and phase: Completed; Phase 2

Conditions: Postoperative Complications

Treatments: Drug: Placebo Oral Capsule; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT03023501

E-13-902

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA 1 and 2
• BMI 35 - 45

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

Gabapentin 1200mg capsule was administered orally 2 hours before surgery

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

Placebo capsule was prepared by hospital pharmacy and was administered orally 2 hours before surgery.

Treatment:

Drug: Placebo Oral Capsule