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Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Shaare Zedek Medical Center Identifier:
First received: October 13, 2009
Last updated: February 1, 2010
Last verified: February 2010

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.

Condition Intervention
Postoperative Pain
Drug: extended-release tramadol
Drug: paracetamol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Patient satisfaction will be evaluated by a telephone interview [ Time Frame: up to 48 hours ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01024348

Contact: Yaacov Gozal, MD 972-2-6555614
Contact: Anna Lev, MD 972-2-6555104

Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Yaacov Gozal, MD    972-2-6555614   
Principal Investigator: Yaacov Gozal, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Principal Investigator: Yaacov Gozal, MD Shaare Zedek Medical center, Jerusalem, Israel
  More Information

Responsible Party: Yaacov Gozal, MD, Shaare Zedek Medical Center, Jerusalem, Israel Identifier: NCT01024348     History of Changes
Other Study ID Numbers: gozal123456
Study First Received: October 13, 2009
Last Updated: February 1, 2010

Keywords provided by Shaare Zedek Medical Center:
Surgery, knee arthroscopy
Pain, postoperative
tramadol, extended release

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics processed this record on May 25, 2017