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

July 19, 2012
August 10, 2012
January 2009
November 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01666379 on ClinicalTrials.gov Archive Site
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
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01666379
ForefootFenta vs.2
No
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