Clinical trial NCT03023501: Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy
Official title: The Effect of Gabapentin on Postoperataive Pain ,Morphine Sparing Effect and Preoperative Anxiety in Bariatric Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Complications
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* ASA 1 and 2
* BMI 35 - 45

Exclusion Criteria:

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

Primary outcomes:
measure: Post operative Morphine requirement
timeFrame: At 2 hours in Post Anesthesia Care Unit
measure: Post operative pain
timeFrame: At 2 hours in Post Anesthesia Care Unit
measure: Post operative Morphine requirement
timeFrame: 4 hourly in the ward for 24 hours
measure: Post operative pain
timeFrame: 4 hourly in the ward for 24 hours
Secondary outcomes:
measure: Preoperative anxiety
timeFrame: 30 minutes before surgery
Other outcomes:
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