Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Intervertebral Disc Prolapse |
| Intervention | Drug: Pregabalin Drug: Gabapentin |
| Phase | Phase 3 |
| Sponsor | Aga Khan University |
| Responsible Party | Aga Khan University |
| ClinicalTrials.gov Identifier | NCT02120703 |
| First Received | April 19, 2014 |
| Last Updated | April 22, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 19, 2014 |
|---|---|
| Last Updated Date | April 22, 2014 |
| Start Date | February 2011 |
| Estimated Primary Completion Date | October 2011 |
| Current Primary Outcome Measures | Pain [Time Frame: 7 days] [Designated as safety issue: No]Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| 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. |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care |
| Condition | Intervertebral Disc Prolapse |
| Intervention | Drug: Pregabalin Pregablin 75 mg per oral two times a day Drug: Gabapentin Gabapentin 200 mg twice daily per oral |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 78 |
| Estimated Completion Date | October 2011 |
| Estimated Primary Completion Date | October 2011 |
| Eligibility Criteria | 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. |
| Gender | Both |
| Ages | 30 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Pakistan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02120703 |
|---|---|
| Other Study ID Numbers | 173-SUR-ERC-10 |
| Has Data Monitoring Committee | No |
| Information Provided By | Aga Khan University |
| Study Sponsor | Aga Khan University |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Mohsin Qadeer, FCPS The Aga Khan University Hospital, Karachi, Pakistan |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| The Aga Khan University Hospital | Karachi, Sind, Pakistan, 75300 |
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