NCT01024348

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 2, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

October 13, 2009

Last Update Submit

February 1, 2010

Conditions

Postoperative Pain

Keywords

Surgery, knee arthroscopyPain, postoperativetramadol, extended release

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient satisfaction will be evaluated by a telephone interview

    up to 48 hours

Study Arms (2)

Tramadex-OD

ACTIVE COMPARATOR

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

Control group

ACTIVE COMPARATOR

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

Interventions

extended-release tramadolDRUG

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

Also known as: Tramadol, Tramal
Tramadex-OD
paracetamolDRUG

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

Also known as: Acamol, Acetominophen
Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and nonpregnant women
  • Age: 18-65 years
  • ASA classification I or II
  • ambulatory knee arthroscopy under spinal anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

TramadolAcetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsAcetanilidesAnilidesAmidesAniline Compounds

Study Officials

  • Yaacov Gozal, MD

    Shaare Zedek Medical center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaacov Gozal, MD

CONTACT

972-2-6555614gozaly@szmc.org.il

Anna Lev, MD

CONTACT

972-2-6555104anamlev@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

December 2, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

February 2, 2010

Record last verified: 2010-02

Locations

IL(1)