Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
NCT ID: NCT01014520
Last Updated: 2009-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2009-05-31
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Gabapentin
Neurontin
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
Amitriptyline
Elavil
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Tabriz University
OTHER
Responsible Party
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Tabriz University
Principal Investigators
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Dawood Aghamohammadi, MD
Role: STUDY_CHAIR
Tabriz University
Payman Vahedi, MD
Role: PRINCIPAL_INVESTIGATOR
Tabriz University
Locations
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Tabriz University of Medical Sciences
Tabriz, East Azerbayjan, Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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883
Identifier Type: -
Identifier Source: org_study_id
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