Back to resultsPain Management After Forefoot Surgery
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Hallux valgus, Forefoot, transdermal fentanyl
Eligibility 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
Sites / Locations
- The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fentanyl
placebo
Arm Description
Outcomes
Primary Outcome Measures
Consumption of rescue opioid
Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure
Secondary Outcome Measures
Pain on a numerical scale
The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure
Full Information
NCT ID
NCT01666379
First Posted
July 19, 2012
Last Updated
August 10, 2012
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01666379
Brief Title
Pain Management After Forefoot Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Hallux valgus, Forefoot, transdermal fentanyl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Primary Outcome Measure Information:
Title
Consumption of rescue opioid
Description
Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure
Time Frame
on the 1st postoperative day
Secondary Outcome Measure Information:
Title
Pain on a numerical scale
Description
The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure
Time Frame
on the 1st postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital
City
Turku
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Pain Management After Forefoot Surgery
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