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Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy

Primary Purpose

Postoperative Complications

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Gabapentin

Placebo Oral Capsule

About this trial

This is an interventional treatment trial for Postoperative Complications

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

ASA 1 and 2
BMI 35 - 45

Exclusion Criteria:

Patients taking any sedative or tranquillizers
Any contraindication to gabapentin.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

Gabapentin 1200mg capsule was administered orally 2 hours before surgery

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

Outcomes

Primary Outcome Measures

Post operative Morphine requirement

Post operative pain

Post operative Morphine requirement

Post operative pain

Secondary Outcome Measures

Preoperative anxiety

Full Information

NCT ID

NCT03023501

First Posted

January 13, 2017

Last Updated

January 13, 2017

Sponsor

King Saud University

1. Study Identification

Unique Protocol Identification Number

NCT03023501

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Saud University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gabapentin

Arm Type

Experimental

Arm Description

Gabapentin 1200mg capsule was administered orally 2 hours before surgery

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Capsule

Primary Outcome Measure Information:

Title

Post operative Morphine requirement

Time Frame

At 2 hours in Post Anesthesia Care Unit

Title

Post operative pain

Time Frame

At 2 hours in Post Anesthesia Care Unit

Title

Post operative Morphine requirement

Time Frame

4 hourly in the ward for 24 hours

Title

Post operative pain

Time Frame

4 hourly in the ward for 24 hours

Secondary Outcome Measure Information:

Title

Preoperative anxiety

Time Frame

30 minutes before surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA 1 and 2 BMI 35 - 45 Exclusion Criteria: Patients taking any sedative or tranquillizers Any contraindication to gabapentin.

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy

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