Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery

Intervertebral Disc Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120703
• Other study ID #: 173-SUR-ERC-10
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2014
• Last updated: April 22, 2014
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: April 2014
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Intervertebral Disc Prolapse

Intervention

Drug:
• Pregabalin
Pregablin 75 mg per oral two times a day
• Gabapentin
Gabapentin 200 mg twice daily per oral

Locations

Country	Name	City	State
Pakistan	The Aga Khan University Hospital	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain measurement using Visual Analogue Score at 24 hours and 7th day of surgery	7 days	No