Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
Information source: Tabriz University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herniated Disc; Intervertebral Disc Displacement
Intervention: Gabapentin , Amitriptyline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Tabriz University Official(s) and/or principal investigator(s):
Dawood Aghamohammadi, MD, Study Chair, Affiliation: Tabriz University
Payman Vahedi, MD, Principal Investigator, Affiliation: Tabriz University
Overall contact:
Dawood Aghamohammadi, MD, Phone: +98 411 3340830, Ext: 1065, Email: daghamohamadi@yahoo.com
Summary
The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive
analgesia to reduce postoperative pain after lumbar diskectomies.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 30% reduction in opium consumption in either study arms compared to the placebo group
Secondary outcome: 30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dawood Aghamohammadi, MD, Phone: +98 411 3340830, Ext: 1065, Email: daghamohamadi@yahoo.com
Tabriz University of Medical Sciences, Tabriz, East Azerbayjan 5166614756, Iran, Islamic Republic of; Recruiting
Dawood Aghamohammadi, MD, Phone: +98 411 3347054, Ext: 1065, Email: daghamohamadi@yahoo.com
Payman Vahedi, MD, Phone: +98 411 3340830, Email: payman.vahedi@gmail.com
Dawood Aghamohammadi, MD, Principal Investigator
Payman Vahedi, MD, Principal Investigator
Additional Information
Starting date: May 2009
Last updated: November 16, 2009
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