Pain Management After Forefoot Surgery

August 10, 2012 updated by: Riika Merivirta, Turku University Hospital
The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral hallux valgus or hallux rigidus surgery
  • 18-75 yrs old
  • ASA I-III

Exclusion Criteria:

  • previous history of intolerance to the study drug
  • history of alcoholism
  • drug abuse
  • psychological or other emotional problems that are likely to invalidate informed consent
  • sleep apnoea
  • BMI ≥ 35 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Experimental: Fentanyl
Drug: Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of rescue opioid
Time Frame: on the 1st postoperative day
Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure
on the 1st postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on a numerical scale
Time Frame: on the 1st postoperative day
The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure
on the 1st postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ForefootFenta vs.2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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