Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial.
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2011
Shorter than P25 for phase_3
1 active site
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
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedApril 23, 2014
April 1, 2014
8 months
April 19, 2014
April 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery
7 days
Study Arms (2)
gabapentin
ACTIVE COMPARATORPregabalin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years age
- Any gender
- elective micro discectomy for intervertebral disc prolapse
You may not qualify if:
- 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
- \) patients with known allergy to GABA analogues.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Aga Khan University Hospital
Karachi, Sindh, 75300, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohsin Qadeer, FCPS
The Aga Khan University Hospital, Karachi, Pakistan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
April 19, 2014
First Posted
April 23, 2014
Study Start
February 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
April 23, 2014
Record last verified: 2014-04