Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

Shaare Zedek Medical Center

Status: Unknown

Conditions: Postoperative Pain

Treatments: Drug: paracetamol; Drug: extended-release tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT01024348

gozal123456

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Tramadex-OD

Active Comparator group

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.

Treatment:

Drug: extended-release tramadol

Control group

Active Comparator group

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.

Treatment:

Drug: paracetamol