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Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024348
Recruitment Status : Unknown
Verified February 2010 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2009
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: extended-release tramadol Drug: paracetamol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Patient satisfaction will be evaluated by a telephone interview [ Time Frame: up to 48 hours ]

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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024348


Contacts
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Contact: Yaacov Gozal, MD 972-2-6555614 gozaly@szmc.org.il
Contact: Anna Lev, MD 972-2-6555104 anamlev@gmail.com

Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Contact: Yaacov Gozal, MD    972-2-6555614    gozaly@szmc.org.il   
Principal Investigator: Yaacov Gozal, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Yaacov Gozal, MD Shaare Zedek Medical center, Jerusalem, Israel
More Information
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Responsible Party: Yaacov Gozal, MD, Shaare Zedek Medical Center, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT01024348    
Other Study ID Numbers: gozal123456
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: February 2010
Keywords provided by Shaare Zedek Medical Center:
Surgery, knee arthroscopy
Pain, postoperative
tramadol, extended release
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants