Back to resultsPregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
Primary Purpose
Intervertebral Disc Prolapse
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Pregabalin
Gabapentin
Sponsored by
About this trial
This is an interventional supportive care trial for Intervertebral Disc Prolapse focused on measuring Pregabalin, gabapentin, microdiscectomy, pain
Eligibility Criteria
Inclusion Criteria:
- 30-60 years age
- Any gender
- elective micro discectomy for intervertebral disc prolapse
Exclusion Criteria:
- micro discectomy at two or more vertebral levels,
- Instrumentation i.e. pedicle screw fixation, hooks etc.,
- history of steroids or alcohol use,
- Multiple co-morbids i.e. renal failure, chronic liver disease,
- use of anticonvulsant drugs,
- Spinal deformity,
- Obesity (BMI >30), 8) inability to understand and respond VAS and
9) patients with known allergy to GABA analogues.
Sites / Locations
- The Aga Khan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
gabapentin
Pregabalin
Arm Description
Outcomes
Primary Outcome Measures
Pain
Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02120703
Brief Title
Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
Official Title
Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Prolapse
Keywords
Pregabalin, gabapentin, microdiscectomy, pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gabapentin
Arm Type
Active Comparator
Arm Title
Pregabalin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregablin 75 mg per oral two times a day
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 200 mg twice daily per oral
Primary Outcome Measure Information:
Title
Pain
Description
Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
30-60 years age
Any gender
elective micro discectomy for intervertebral disc prolapse
Exclusion Criteria:
micro discectomy at two or more vertebral levels,
Instrumentation i.e. pedicle screw fixation, hooks etc.,
history of steroids or alcohol use,
Multiple co-morbids i.e. renal failure, chronic liver disease,
use of anticonvulsant drugs,
Spinal deformity,
Obesity (BMI >30), 8) inability to understand and respond VAS and
9) patients with known allergy to GABA analogues.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsin Qadeer, FCPS
Organizational Affiliation
The Aga Khan University Hospital, Karachi, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Aga Khan University Hospital
City
Karachi
State/Province
Sind
ZIP/Postal Code
75300
Country
Pakistan
12. IPD Sharing Statement
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Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
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