Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
- Conditions
- Brachial Plexus BlockPain, Postoperative
- Interventions
- Registration Number
- NCT03011905
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- Distal radius fracture planned for operation with a volar plate
- 0-20 days after trauma
- AO classification A, B, and C
- ASA 1 and 2
- Age 18-65
- BMI 18-35
- Able to communicate in Norwegian
- Chronic pain
- Other injuries
- Pregnancy
- Known allergic reactions to medicines used in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control NaCl (Control) Single dose of NaCl, 4 ml, iv during operation. Control Paracetamol Single dose of NaCl, 4 ml, iv during operation. Control EtoriCoxib Single dose of NaCl, 4 ml, iv during operation. Dexamethasone Dexamethasone Single dose of dexamethasone (Dexagalen) 16 mg iv during operation. Dexamethasone Paracetamol Single dose of dexamethasone (Dexagalen) 16 mg iv during operation. Dexamethasone Oxycodone Single dose of dexamethasone (Dexagalen) 16 mg iv during operation. Dexamethasone EtoriCoxib Single dose of dexamethasone (Dexagalen) 16 mg iv during operation. Dexamethasone Ropivacaine Single dose of dexamethasone (Dexagalen) 16 mg iv during operation. Control Oxycodone Single dose of NaCl, 4 ml, iv during operation. Control Ropivacaine Single dose of NaCl, 4 ml, iv during operation.
- Primary Outcome Measures
Name Time Method Differences between groups in highest pain scores first 24 hours after surgery 24 hours
- Secondary Outcome Measures
Name Time Method Differences in side effects 1 year Differences between groups in nausea postoperatively assessed with Likert scale 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours Likert scale
Differences between groups in vomiting postoperatively assessed with Likert scale 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours Likert scale
Differences between groups in itching postoperatively assessed with Likert scale 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours Likert scale
Differences in time to first pain score under 4 after block resolution 7 days Differences in pain scores after 6 months and 1 year 6 months and 1 year Differences between groups in sleep quality assessed with Likert scale 24 hours Likert scale
Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks 6 weeks Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours Differences in analgesic consumption 1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year Differences between groups in sedation postoperatively assessed with Likert scale 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours Likert scale
Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks 36 hours, 3 days, 7 days, 6 weeks Differences in block duration 20 hours
Trial Locations
- Locations (1)
Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
🇳🇴Oslo, Norway