Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

February 1, 2010 updated by: Shaare Zedek Medical Center

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tramadex-OD
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
30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD
Other Names:
  • Tramadol
  • Tramal
Active Comparator: Control group
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
in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)
Other Names:
  • Acamol
  • Acetominophen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Yaacov Gozal, MD, Shaare Zedek Medical Center, Jerusalem, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gozal123456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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