Tramadol vs.Tramadol With Paracetamol

Study Overview
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Brief Summary
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This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Detailed Description
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Background: Despite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate. Aims: This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery. Study Design: In this study we have randomized 60 patients into two treatment groups. In Group Tramadol patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals. Methods: Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.

Official Title
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Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Drug: Tramadol
* Drug: Paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation. Exclusion Criteria: Patients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is ≥30 kg/m2 were excluded from the study.

Ages Eligible for Study
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Minimum Age: 30 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol<br>Group Tramadol patients received tramadol 1 mg kg-1 iv | Drug: Tramadol<br>* Tramadol iv<br>|
| Active Comparator: Tramadol-Paracetamol<br>Group Tramadol-Paracetamol patients received paracetamol 1 gr iv in addition to tramadol 1 mg kg-1 iv 30 minutes before the end of the operation and after the operation at 6 hour intervals for 24 hours | Drug: Tramadol<br>* Tramadol iv<br>Drug: Paracetamol<br>* Paracetamol iv<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of pain | Self reported pain intensity | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tramadol consumption | Total tramadol consumption during time frame | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Discectomy, Acetaminophen, Tramadol, Discogenic pain