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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Tabriz University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT01014520
First received: November 14, 2009
Last updated: November 16, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Herniated Disc
Intervertebral Disc Displacement
Drug: Gabapentin , Amitriptyline
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • 30% reduction in opium consumption in either study arms compared to the placebo group [ Time Frame: Within the first 24 hours after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014520

Contacts
Contact: Dawood Aghamohammadi, MD +98 411 3340830 ext 1065 daghamohamadi@yahoo.com
Contact: Payman Vahedi, MD +98 411 3340830 payman.vahedi@gmail.com

Locations
Iran, Islamic Republic of
Tabriz University of Medical Sciences Recruiting
Tabriz, East Azerbayjan, Iran, Islamic Republic of, 5166614756
Contact: Dawood Aghamohammadi, MD    +98 411 3347054 ext 1065    daghamohamadi@yahoo.com   
Contact: Payman Vahedi, MD    +98 411 3340830    payman.vahedi@gmail.com   
Principal Investigator: Dawood Aghamohammadi, MD         
Principal Investigator: Payman Vahedi, MD         
Sponsors and Collaborators
Tabriz University
Investigators
Study Chair: Dawood Aghamohammadi, MD Tabriz University
Principal Investigator: Payman Vahedi, MD Tabriz University
  More Information

No publications provided

Responsible Party: Tabriz University
ClinicalTrials.gov Identifier: NCT01014520     History of Changes
Other Study ID Numbers: 883
Study First Received: November 14, 2009
Last Updated: November 16, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Tabriz University:
Lumbar
Diskectomy
Laminectomy

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Pain, Postoperative
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Amitriptyline
Gabapentin
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014