Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01014520
• Other study ID #: 883
• Status: Recruiting
• Phase: Phase 2
• First received: November 14, 2009
• Last updated: November 16, 2009
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2009
• Source: Tabriz University
• Contact: Dawood Aghamohammadi, MD
• Phone: +98 411 3340830
• Email: daghamohamadi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herniated Disc
• Intervertebral Disc Displacement
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tabriz University of Medical Sciences	Tabriz	East Azerbayjan

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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