Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The primary endpoint is difference in the highest pain score first 24 hours after surgery. The investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.
This double-blind randomized clinical study evaluates pain, analgesic consumption and different measurements of patients satisfaction after operations for distal radius fractures with a volar plate in the day-care surgery unit. All patients will receive paracetamol and etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a single dose of 16 mg dexamethasone during the operation. Patients in the control group will receive NaCl iv. After surgery, iv and oral rapid release oxycodone as needed while in hospital. After discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3 doses. Rapid release oxycodone as needed. Patients will be followed up by telephone interviews at different times after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
4 ml DexaGalen 4 mg/ml
4 ml NaCl 9 mg/ml
Premedication and as needed after operation
Premedication and first 2 postoperative days.
Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
In brachial plexus block
Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
Oslo, Norway
Differences between groups in highest pain scores first 24 hours after surgery
Time frame: 24 hours
Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks
Time frame: 36 hours, 3 days, 7 days, 6 weeks
Differences in pain scores after 6 months and 1 year
Time frame: 6 months and 1 year
Differences in analgesic consumption
Time frame: 1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year
Differences in block duration
Time frame: 20 hours
Differences between groups in sedation postoperatively assessed with Likert scale
Likert scale
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in sleep quality assessed with Likert scale
Likert scale
Time frame: 24 hours
Differences between groups in nausea postoperatively assessed with Likert scale
Likert scale
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in vomiting postoperatively assessed with Likert scale
Likert scale
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in itching postoperatively assessed with Likert scale
Likert scale
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences in time to first pain score under 4 after block resolution
Time frame: 7 days
Differences in side effects
Time frame: 1 year
Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks
Time frame: 6 weeks
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