NCT03023501

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 13, 2017

Last Update Submit

January 13, 2017

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (4)

  • Post operative Morphine requirement

    At 2 hours in Post Anesthesia Care Unit

  • Post operative pain

    At 2 hours in Post Anesthesia Care Unit

  • Post operative Morphine requirement

    4 hourly in the ward for 24 hours

  • Post operative pain

    4 hourly in the ward for 24 hours

Secondary Outcomes (1)

  • Preoperative anxiety

    30 minutes before surgery

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin 1200mg capsule was administered orally 2 hours before surgery

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Capsule

Interventions

GabapentinDRUG
Gabapentin
Placebo Oral CapsuleDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1 and 2
  • BMI 35 - 45

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MUEEN ULLAH KHAN

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 18, 2017

Study Start

March 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share