Clinical trial NCT03011905: Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
Official title: Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brachial Plexus Block
Pain, Postoperative
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences between groups in highest pain scores first 24 hours after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
timeFrame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
measure: Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks
timeFrame: 36 hours, 3 days, 7 days, 6 weeks
measure: Differences in pain scores after 6 months and 1 year
timeFrame: 6 months and 1 year
measure: Differences in analgesic consumption
timeFrame: 1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year
measure: Differences in block duration
timeFrame: 20 hours
measure: Differences between groups in sedation postoperatively assessed with Likert scale
timeFrame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
measure: Differences between groups in sleep quality assessed with Likert scale
timeFrame: 24 hours
measure: Differences between groups in nausea postoperatively assessed with Likert scale
timeFrame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
measure: Differences between groups in vomiting postoperatively assessed with Likert scale
timeFrame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
measure: Differences between groups in itching postoperatively assessed with Likert scale
timeFrame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
measure: Differences in time to first pain score under 4 after block resolution
timeFrame: 7 days
measure: Differences in side effects
timeFrame: 1 year
measure: Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
Study officials:
affiliation: Oslo University Hospital
name: Anne Holmberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.