Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01024348

Enrollment

100

Registered

2009-12-02

Start date

2009-12-31

Completion date

2011-12-31

Last updated

2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Surgery, knee arthroscopy, Pain, postoperative, tramadol, extended release

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.

Interventions

DRUGextended-release tramadol

30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD

DRUGparacetamol

in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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	up to 48 hours

Secondary

Measure	Time frame
Patient satisfaction will be evaluated by a telephone interview	up to 48 hours

Countries

Israel

Contacts

Primary ContactYaacov Gozal, MD

gozaly@szmc.org.il972-2-6555614

Backup ContactAnna Lev, MD

anamlev@gmail.com972-2-6555104

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026