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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

November 14, 2009
November 16, 2009
May 2009
February 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01014520 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Herniated Disc
  • Intervertebral Disc Displacement
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: Gabapentin
    Neurontin
    Intervention: Drug: Gabapentin , Amitriptyline
  • Experimental: Amitriptyline
    Elavil
    Intervention: Drug: Gabapentin , Amitriptyline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
March 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Dawood Aghamohammadi, MD +98 411 3340830 ext 1065 daghamohamadi@yahoo.com
Contact: Payman Vahedi, MD +98 411 3340830 payman.vahedi@gmail.com
Iran, Islamic Republic of
 
NCT01014520
883
Yes
Tabriz University
Tabriz University
Not Provided
Study Chair: Dawood Aghamohammadi, MD Tabriz University
Principal Investigator: Payman Vahedi, MD Tabriz University
Tabriz University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP