Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

Study Overview
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Brief Summary
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Extended-release tramadol is indicated for the management of moderate to severe pain in adults who require around-the-clock treatment. It provides an extended duration of action, more constant plasma concentrations, a reduced dosing frequency, and the potential for improved compliance and therapeutic outcomes. The present study was designed to evaluate the safety and effectiveness of this medication in the treatment of early postoperative pain after knee arthroscopy.

Official Title
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Open-label Study of the Safety and Effectiveness of Short-term Therapy With Extended-release Tramadol (TRAMADEX-OD) in the Management of Pain After Knee Arthroscopy.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: extended-release tramadol
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and nonpregnant women Age: 18-65 years ASA classification I or II ambulatory knee arthroscopy under spinal anesthesia Exclusion Criteria: Pregnancy Intolerance to any opioid, tramadol or paracetamol spine surgery in the past renal or hepatic impairment cardiac or respiratory conditions that put the patient at risk for respiratory depression patients receiving: monoamine oxidase inhibitors, carbamazepine, quinidine, selective serotonin reuptake inhibitors or tricyclic antidepressants

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadex-OD<br>Patients will undergo knee arthroscopy under spinal anesthesia without any opioid. 30 minutes prior to surgery and 24 hours afterwards, patients will take a tablet of 100 mg Tramadex-OD. Breakthrough pain will be managed with 1 gr paracetamol (per os) as needed. | Drug: extended-release tramadol<br>* 30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD<br>* Other names: Tramal;|
| Active Comparator: Control group<br>Patients will undergo knee arthroscopy under spinal anesthesia without any opioid.Postoperative pain will be managed throughout the study with 1 gr paracetamol (per os) every 6 hours as required. | Drug: paracetamol<br>* in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)<br>* Other names: Acetominophen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and effectiveness of TRAMADEX-OD will be evaluated by recording adverse events and using a visual analogue score for pain evaluation |  | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction will be evaluated by a telephone interview |  | up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, knee arthroscopy, Pain, postoperative, tramadol, extended release