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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 19, 2012
Last Updated Date	August 10, 2012
Start Date ^ICMJE	January 2009
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 10, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01666379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 10, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pain Management After Forefoot Surgery
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Postoperative Pain
Intervention ^ICMJE	Drug: Fentanyl
Study Arm (s)	Experimental: Fentanyl Intervention: Drug: Fentanyl Placebo Comparator: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT01666379
Other Study ID Numbers ^ICMJE	ForefootFenta vs.2
Has Data Monitoring Committee	No
Responsible Party	Riika Merivirta, Turku University Hospital
Study Sponsor ^ICMJE	Turku University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Turku University Hospital
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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