Pain Management After Forefoot Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01666379
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : August 16, 2012
Information provided by (Responsible Party):
Riika Merivirta, Turku University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Pain Drug: Fentanyl Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fentanyl Drug: Fentanyl
Placebo Comparator: placebo

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01666379

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

Responsible Party: Riika Merivirta, M.D., Turku University Hospital Identifier: NCT01666379     History of Changes
Other Study ID Numbers: ForefootFenta vs.2
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012

Keywords provided by Riika Merivirta, Turku University Hospital:
Hallux valgus
transdermal fentanyl

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General