Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Drug: extended-release tramadol; Drug: paracetamol

• Registration Number: NCT01024348
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-13
• Study Start: 2009-12
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02
• Primary Completion: 2010-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadex-OD	extended-release tramadol	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.
Control group	paracetamol	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient satisfaction will be evaluated by a telephone interview	up to 48 hours

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel