Brachial Plexus Block, Pain, Postoperative
Conditions
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.
Interventions
DRUGRopivacaine
In brachial plexus block
DRUGParacetamol
Premedication and as needed after operation
DRUGDexamethasone
4 ml DexaGalen 4 mg/ml
DRUGNaCl (Control)
4 ml NaCl 9 mg/ml
DRUGEtoriCoxib
Premedication and first 2 postoperative days.
DRUGOxycodone
Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Chronic pain * Other injuries * Pregnancy * Known allergic reactions to medicines used in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences between groups in highest pain scores first 24 hours after surgery | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 pain scores after 36 hours, 3 days, 7 days, 6 weeks | 36 hours, 3 days, 7 days, 6 weeks | — |
| Differences in pain scores after 6 months and 1 year | 6 months and 1 year | — |
| 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 in block duration | 20 hours | — |
| 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 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 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 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 side effects | 1 year | — |
| Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks | 6 weeks | — |
| Differences between groups in sleep quality assessed with Likert scale | 24 hours | Likert scale |
Countries
Norway
Outcome results
None listed