Postoperative Pain Clinical Trial
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Consumption of rescue opioid | Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure | on the 1st postoperative day | No |
Secondary | Pain on a numerical scale | The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure | on the 1st postoperative day | No |
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