Back to resultsEfficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
Primary Purpose
Herniated Disc, Intervertebral Disc Displacement
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Gabapentin , Amitriptyline
Sponsored by
About this trial
This is an interventional treatment trial for Herniated Disc focused on measuring Lumbar, Diskectomy, Laminectomy
Eligibility 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
Sites / Locations
- Tabriz University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gabapentin
Amitriptyline
Arm Description
Neurontin
Elavil
Outcomes
Primary Outcome Measures
30% reduction in opium consumption in either study arms compared to the placebo group
Secondary Outcome Measures
30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01014520
Brief Title
Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
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 Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tabriz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Disc, Intervertebral Disc Displacement
Keywords
Lumbar, Diskectomy, Laminectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Neurontin
Arm Title
Amitriptyline
Arm Type
Experimental
Arm Description
Elavil
Intervention Type
Drug
Intervention Name(s)
Gabapentin , Amitriptyline
Other Intervention Name(s)
Neurontin, Elavil
Intervention Description
Capsule, 300 mg, oral, single dose 2 hours before surgery
Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery
Primary Outcome Measure Information:
Title
30% reduction in opium consumption in either study arms compared to the placebo group
Time Frame
Within the first 24 hours after surgery
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dawood Aghamohammadi, MD
Phone
+98 411 3340830
Ext
1065
Email
daghamohamadi@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Payman Vahedi, MD
Phone
+98 411 3340830
Email
payman.vahedi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawood Aghamohammadi, MD
Organizational Affiliation
Tabriz University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Payman Vahedi, MD
Organizational Affiliation
Tabriz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tabriz University of Medical Sciences
City
Tabriz
State/Province
East Azerbayjan
ZIP/Postal Code
5166614756
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawood Aghamohammadi, MD
Phone
+98 411 3347054
Ext
1065
Email
daghamohamadi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Payman Vahedi, MD
Phone
+98 411 3340830
Email
payman.vahedi@gmail.com
First Name & Middle Initial & Last Name & Degree
Dawood Aghamohammadi, MD
First Name & Middle Initial & Last Name & Degree
Payman Vahedi, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
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