Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery

April 22, 2014 updated by: Ghulam Murtaza, Aga Khan University

Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial.

Pregabalin is claimed to have superior analgesic effect at lower doses and better pharmacological profile as compared to gabapentin esp. in perioperative pain control after major surgeries like intervertebral disc surgery.

The investigators found that pregabalin is equivalent to gabapentin for relief of post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sind
      • Karachi, Sind, Pakistan, 75300
        • The Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 30-60 years age
  • Any gender
  • elective micro discectomy for intervertebral disc prolapse

Exclusion Criteria:

  1. micro discectomy at two or more vertebral levels,
  2. Instrumentation i.e. pedicle screw fixation, hooks etc.,
  3. history of steroids or alcohol use,
  4. Multiple co-morbids i.e. renal failure, chronic liver disease,
  5. use of anticonvulsant drugs,
  6. Spinal deformity,
  7. Obesity (BMI >30), 8) inability to understand and respond VAS and

9) patients with known allergy to GABA analogues.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin
Drug: Pregabalin
Pregablin 75 mg per oral two times a day
Active Comparator: gabapentin
Drug: Gabapentin
Gabapentin 200 mg twice daily per oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 7 days
Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Mohsin Qadeer, FCPS, The Aga Khan University Hospital, Karachi, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 19, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Estimate)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173-SUR-ERC-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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