Pain Management After Forefoot Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Riika Merivirta, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01666379
First received: July 19, 2012
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Consumption of rescue opioid [ Time Frame: on the 1st postoperative day ] [ Designated as safety issue: No ]
    Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure


Secondary Outcome Measures:
  • Pain on a numerical scale [ Time Frame: on the 1st postoperative day ] [ Designated as safety issue: No ]
    The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure


Enrollment: 60
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fentanyl Drug: Fentanyl
Placebo Comparator: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666379

Locations
Finland
The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Riika Merivirta, M.D., Turku University Hospital
ClinicalTrials.gov Identifier: NCT01666379     History of Changes
Other Study ID Numbers: ForefootFenta vs.2
Study First Received: July 19, 2012
Last Updated: August 10, 2012
Health Authority: Finland: Finnish Medicines Agency
European Union: European Medicines Agency

Keywords provided by Turku University Hospital:
Hallux valgus
Forefoot
transdermal fentanyl

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 17, 2014