Pain after operations for radius fractures.
Phase 1
- Conditions
- Pain after radius fracture fixation by a volar plate.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-000684-16-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Radius fractures planned operated with a polar plate fixation. Age 18-65. ASA class 1 and 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Chronic pain. Neurological disease. Nerve impairment of the upper limb. Diabetes. Any known allergic reaction to any medication in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To find out if single doses of dexamethasone and etoricoxib will reduce pain after radius fracture operation. ;Secondary Objective: To find out if single doses of dexamethasone and etoricoxib will reduce analgesic consumption and improve daily function after radius fracture operations.;Primary end point(s): Difference in highest VNRS score first 24 hours after the operation.;Timepoint(s) of evaluation of this end point: First 24 hours after the operation.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Differences in VNRS scores at different times after the operation. Differences in analgesic consumption after the operation. Differences in daily function after the operation.;Timepoint(s) of evaluation of this end point: 30 min, 1 hour, 2 hrs, 4 hrs, 8 hrs, 24 hrs, 36 hrs, 72 hrs, 7 days, 6 weeks, 6 months, 1 year