Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

Study Overview
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Brief Summary
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In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.

Detailed Description
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Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects

Official Title
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Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: dexketoprofen trometamol
* Drug: tenoxicam
* Drug: serum physiologic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-2 between 18-65 age elective lumbar disc surgery Exclusion Criteria: history of gastrointestinal bleeding peptic ulcer disease bleeding disorders history of allergic reactions to NSAİDs chronic pain syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: dexketoprofen trometamol<br>before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc | Drug: dexketoprofen trometamol<br>* before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc<br>* Other names: arveles;|
| Active Comparator: tenoxicam<br>before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc | Drug: tenoxicam<br>* before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc<br>* Other names: oksamen;|
| Placebo Comparator: serum physiologic<br>before end of the surgery via administration intravenous 0.9 % NaCl 100 cc | Drug: serum physiologic<br>* before end of the surgery via administration intravenous 0.9 % NaCl 100 cc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption | morphine consumption (patient control analgesia procedure) was recorded | postoperative 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | visual analog scale on rest and movement was recorded | postoperative 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexketoprofen trometamol, tenoxicam, postoperative pain