Intervertebral Disc Displacement Clinical Trial
Official title:
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
The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | March 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Tabriz University of Medical Sciences | Tabriz | East Azerbayjan |
Lead Sponsor | Collaborator |
---|---|
Tabriz University |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30% reduction in opium consumption in either study arms compared to the placebo group | Within the first 24 hours after surgery | Yes | |
Secondary | 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 | Yes |
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