Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

Postoperative Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01024348
• Other study ID #: gozal123456
• Status: Not yet recruiting
• Phase: N/A
• First received: October 13, 2009
• Last updated: February 1, 2010
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2010
• Source: Shaare Zedek Medical Center
• Contact: Yaacov Gozal, MD
• Phone: 972-2-6555614
• Email: gozaly[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• extended-release tramadol
30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD
• paracetamol
in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Patient satisfaction will be evaluated by a telephone interview		up to 48 hours	No