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

NCT ID: NCT01014520

Last Updated: 2009-11-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Herniated Disc Intervertebral Disc Displacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gabapentin

Neurontin

Group Type EXPERIMENTAL

Gabapentin , Amitriptyline

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Gabapentin , Amitriptyline

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Neurontin Elavil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tabriz University

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Dawood Aghamohammadi, MD

Role: CONTACT

+98 411 3340830 ext. 1065

Payman Vahedi, MD

Role: CONTACT

+98 411 3340830

Facility Contacts

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Dawood Aghamohammadi, MD

Role: primary

+98 411 3347054 ext. 1065

Payman Vahedi, MD

Role: backup

+98 411 3340830

Other Identifiers

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883

Identifier Type: -

Identifier Source: org_study_id

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