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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-04-05

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.

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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.

Conditions

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Brachial Plexus Block Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

4 ml DexaGalen 4 mg/ml

Paracetamol

Intervention Type DRUG

Premedication and as needed after operation

EtoriCoxib

Intervention Type DRUG

Premedication and first 2 postoperative days.

Oxycodone

Intervention Type DRUG

Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.

Ropivacaine

Intervention Type DRUG

In brachial plexus block

Control

Single dose of NaCl, 4 ml, iv during operation.

Group Type PLACEBO_COMPARATOR

NaCl (Control)

Intervention Type DRUG

4 ml NaCl 9 mg/ml

Paracetamol

Intervention Type DRUG

Premedication and as needed after operation

EtoriCoxib

Intervention Type DRUG

Premedication and first 2 postoperative days.

Oxycodone

Intervention Type DRUG

Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.

Ropivacaine

Intervention Type DRUG

In brachial plexus block

Interventions

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Dexamethasone

4 ml DexaGalen 4 mg/ml

Intervention Type DRUG

NaCl (Control)

4 ml NaCl 9 mg/ml

Intervention Type DRUG

Paracetamol

Premedication and as needed after operation

Intervention Type DRUG

EtoriCoxib

Premedication and first 2 postoperative days.

Intervention Type DRUG

Oxycodone

Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.

Intervention Type DRUG

Ropivacaine

In brachial plexus block

Intervention Type DRUG

Other Intervention Names

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DexaGalen NaCl Arcoxia OxyContin OxyNorm

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