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Pain Management After Forefoot Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666379
First Posted: August 16, 2012
Last Update Posted: August 16, 2012
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.
Information provided by (Responsible Party):
Riika Merivirta, Turku University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Riika Merivirta, Turku University Hospital:

Primary Outcome Measures:
  • 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:
  • 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


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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Riika Merivirta, M.D., Turku University Hospital
ClinicalTrials.gov Identifier: NCT01666379     History of Changes
Other Study ID Numbers: ForefootFenta vs.2
First Submitted: July 19, 2012
First Posted: August 16, 2012
Last Update Posted: August 16, 2012
Last Verified: August 2012

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

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