Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
Comparative Effects of Single Dose Preemptive Gabapentin or Amitriptyline on Postoperative Pain and Opioid Consumption in Single Level Lumbar Laminectomy and Diskectomy: A Double Blind RCT With Placebo Control
1 other identifier
interventional
120
1 country
1
Brief Summary
The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 14, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedNovember 17, 2009
November 1, 2009
9 months
November 14, 2009
November 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
30% reduction in opium consumption in either study arms compared to the placebo group
Within the first 24 hours after surgery
Secondary Outcomes (1)
30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group
Within the first 24 hours after surgery
Study Arms (2)
Gabapentin
EXPERIMENTALNeurontin
Amitriptyline
EXPERIMENTALElavil
Interventions
Capsule, 300 mg, oral, single dose 2 hours before surgery Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery
Eligibility Criteria
You may qualify if:
- Signed Informed Consent
- Age:18 to 60
- Weight: 60 to 80 Kg
- ASA Class: I,II
- Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation
- Single level lumbar disk herniation unresponsive to medical treatment
You may not qualify if:
- Previous consumption of Gabapentin or Amitriptyline
- Known allergy to investigated drugs
- Reluctant to sign informed consent
- Previous history of intolerance to narcotics
- Simultaneous lumbar diskectomy and a fusion technique
- Known renal failure
- Pregnancy
- Contraindications to Amitriptyline or Gabapentin prescription
- Unable to use PCA
- Habitual use of alcohol or opium
- History of analgesic consumption during the last 24hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tabriz University of Medical Sciences
Tabriz, East Azerbayjan, 5166614756, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dawood Aghamohammadi, MD
Tabriz University
- PRINCIPAL INVESTIGATOR
Payman Vahedi, MD
Tabriz University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 14, 2009
First Posted
November 17, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2010
Study Completion
March 1, 2010
Last Updated
November 17, 2009
Record last verified: 2009-11