Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block

Conditions
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Brachial Plexus Block, Pain, Postoperative

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: NaCl (Control)
* Drug: Paracetamol
* Drug: EtoriCoxib
* Drug: Oxycodone
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Single dose of dexamethasone (Dexagalen) 16 mg iv during operation. | Drug: Dexamethasone<br>* 4 ml DexaGalen 4 mg/ml<br>* Other names: DexaGalen;Drug: Paracetamol<br>* Premedication and as needed after operation<br>Drug: EtoriCoxib<br>* Premedication and first 2 postoperative days.<br>* Other names: Arcoxia;Drug: Oxycodone<br>* Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.<br>* Other names: OxyNorm;Drug: Ropivacaine<br>* In brachial plexus block<br>|
| Placebo Comparator: Control<br>Single dose of NaCl, 4 ml, iv during operation. | Drug: NaCl (Control)<br>* 4 ml NaCl 9 mg/ml<br>* Other names: NaCl;Drug: Paracetamol<br>* Premedication and as needed after operation<br>Drug: EtoriCoxib<br>* Premedication and first 2 postoperative days.<br>* Other names: Arcoxia;Drug: Oxycodone<br>* Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.<br>* Other names: OxyNorm;Drug: Ropivacaine<br>* In brachial plexus block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between groups in highest pain scores first 24 hours after surgery |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Likert scale | 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 | 24 hours | 
| Differences between groups in nausea postoperatively assessed with Likert scale | Likert scale | 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 | 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 | 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 |  | 7 days | 
| Differences in side effects |  | 1 year | 
| Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks |  | 6 weeks |