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

Study Overview
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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.

Official Title
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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

Conditions
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Herniated Disc, Intervertebral Disc Displacement

Intervention / Treatment
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* Drug: Gabapentin , Amitriptyline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Neurontin | Drug: Gabapentin , Amitriptyline<br>* Capsule, 300 mg, oral, single dose 2 hours before surgery Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery<br>* Other names: Elavil;|
| Experimental: Amitriptyline<br>Elavil | Drug: Gabapentin , Amitriptyline<br>* Capsule, 300 mg, oral, single dose 2 hours before surgery Capsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery<br>* Other names: Elavil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30% reduction in opium consumption in either study arms compared to the placebo group |  | Within the first 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group |  | Within the first 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar, Diskectomy, Laminectomy