Postoperative Analgesia in Laminectomy

Study Overview
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Brief Summary
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Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.

Detailed Description
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Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.

Official Title
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The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain

Conditions
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Postoperative Pain, Postoperative Laminectomy Pain

Intervention / Treatment
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* Drug: 550 mg naproxen sodium and 30mg codeine
* Drug: 300 mg paracetamol and 30 mg codeine
* Drug: placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery Exclusion Criteria: were known allergies to any of the drugs used in this study peptic ulcer disease hepatic and renal dysfunction, emergency surgery inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 550 mg naproxen sodium and 30mg codeine<br>Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. | Drug: 550 mg naproxen sodium and 30mg codeine<br>* Postoperative contramal consumption, pain intensity, side effects<br>* Other names: Apranax plus;|
| Active Comparator: 300 mg paracetamol and 30 mg codeine<br>Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. | Drug: 300 mg paracetamol and 30 mg codeine<br>* Postoperative contramal consumption, pain intensity, side effects<br>* Other names: geralgine K;|
| Placebo Comparator: Placebo<br>Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. | Drug: placebo tablet<br>* Postoperative contramal consumption, pain intensity, side effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contramal consumption | To assess contramal consumption | Postoperative 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | nausea and vomiting | postoperative 24 hour | 
| Pain intensity | To assess postoperative pain intensity by visual analog scale | postoperative 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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naproxen sodium codeine, paracetamol codeine, disk surgery