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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
July 19, 2012
August 16, 2012
August 16, 2012
January 2009
November 2010   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Pain Management After Forefoot Surgery
Not Provided
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Postoperative Pain
Drug: Fentanyl
  • Experimental: Fentanyl
    Intervention: Drug: Fentanyl
  • Placebo Comparator: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2010
November 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01666379
ForefootFenta vs.2
No
Not Provided
Not Provided
Riika Merivirta, Turku University Hospital
Turku University Hospital
Not Provided
Not Provided
Turku University Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP