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Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
extended-release tramadol
paracetamol
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Surgery, knee arthroscopy, Pain, postoperative, tramadol, extended release

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tramadex-OD

Control group

Arm Description

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.

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.

Outcomes

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

Secondary Outcome Measures

Patient satisfaction will be evaluated by a telephone interview

Full Information

First Posted
October 13, 2009
Last Updated
February 1, 2010
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01024348
Brief Title
Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Surgery, knee arthroscopy, Pain, postoperative, tramadol, extended release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tramadex-OD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
extended-release tramadol
Other Intervention Name(s)
Tramadol, Tramal
Intervention Description
30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Acamol, Acetominophen
Intervention Description
in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Patient satisfaction will be evaluated by a telephone interview
Time Frame
up to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaacov Gozal, MD
Phone
972-2-6555614
Email
gozaly@szmc.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Lev, MD
Phone
972-2-6555104
Email
anamlev@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaacov Gozal, MD
Organizational Affiliation
Shaare Zedek Medical center, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaacov Gozal, MD
Phone
972-2-6555614
Email
gozaly@szmc.org.il
First Name & Middle Initial & Last Name & Degree
Yaacov Gozal, MD

12. IPD Sharing Statement

Learn more about this trial

Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

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