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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2010

Pain suppression plays a decisive role in patients' satisfaction following lumbar diskectomies, as the psychological component of the pain is a major cause of treatment failure.

Controversy exists whether preemptive prescription of gabapentin, as a known contributor to reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of amitriptyline and gabapentin in this group of neurosurgical patients.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin , Amitriptyline
  • Capsule, 300 mg, oral, single dose 2 hours before surgery Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Gabapentin
  • Neurontin
• Experimental: Amitriptyline
  • Elavil

Primary Measures

• 30% reduction in opium consumption in either study arms compared to the placebo group
  • Time Frame: Within the first 24 hours after surgery
    Safety Issue?: Yes

Secondary Measures

• 30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group
  • Time Frame: Within the first 24 hours after surgery
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Tabriz University

Overall Clinical Trial Officials and Contacts

Dawood Aghamohammadi, MD Study Chair Tabriz University  

Overall Contact: Dawood Aghamohammadi, MD +98 411 3340830 daghamohamadi@yahoo.com

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01014520

Study ID Number: 883

ClinicalTrials.gov Identifier: NCT01014520

Health Authority: Iran: Ethics Committee