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

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

Study Overview

• Status: Unknown
• Conditions: Intervertebral Disc Displacement; Herniated Disc
• Intervention / Treatment: Drug: Gabapentin , Amitriptyline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dawood Aghamohammadi, MD; Phone Number: 1065 +98 411 3340830; Email: daghamohamadi@yahoo.com
• Study Contact Backup: Name: Payman Vahedi, MD; Phone Number: +98 411 3340830; Email: payman.vahedi@gmail.com

Study Locations

• Iran, Islamic Republic of
  • East Azerbayjan
    • Tabriz, East Azerbayjan, Iran, Islamic Republic of, 5166614756
      • Recruiting
      • Tabriz University of Medical Sciences
      • Contact: Payman Vahedi, MD; Phone Number: +98 411 3340830; Email: payman.vahedi@gmail.com
      • Contact: Dawood Aghamohammadi, MD; Phone Number: 1065 +98 411 3347054; Email: daghamohamadi@yahoo.com
      • Principal Investigator: Dawood Aghamohammadi, MD
      • Principal Investigator: Payman Vahedi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gabapentin; Neurontin	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; Other Names: Neurontin; Elavil
Experimental: Amitriptyline; Elavil	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; Other Names: Neurontin; Elavil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30% reduction in opium consumption in either study arms compared to the placebo group	Within the first 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tabriz University
• Investigators: Study Chair: Dawood Aghamohammadi, MD, Tabriz University; Principal Investigator: Payman Vahedi, MD, Tabriz University

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): February 1, 2010
• Study Completion (Anticipated): March 1, 2010

Study Registration Dates

• First Submitted: November 14, 2009
• First Submitted That Met QC Criteria: November 16, 2009
• First Posted (Estimate): November 17, 2009

Study Record Updates

• Last Update Posted (Estimate): November 17, 2009
• Last Update Submitted That Met QC Criteria: November 16, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Laminectomy; Lumbar; Diskectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Pain, Postoperative; Intervertebral Disc Displacement; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Anti-Anxiety Agents; Anticonvulsants; Antidepressive Agents, Tricyclic; Antimanic Agents; Adrenergic Uptake Inhibitors; Gabapentin; Amitriptyline
• Other Study ID Numbers: 883