Low Dose Dexamethasone for Distal Radius Fractures

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-03-31

Brief Summary

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The addition of the steroid dexamethasone to a single injection of local anesthetic has been shown to significantly prolong the duration of peripheral nerve blockade compared to local anesthetic alone. This allows for improved post-operative pain scores and reduces opioid use in the early post-operative period. However, the use of a steroid adjuvant in regional nerve blocks is generally not considered standard of care, and there is considerable variation among anesthesiologists regarding preferred formulations and the role of adjuvants in regional anesthesia. A recent study from our institution demonstrated the effectiveness of dexamethasone directly mixed with local anesthetic at multiple doses compared to placebo for upper extremity surgery. With this prospective randomized controlled blinded trial, we hope to definitively establish which method of adjuvant dexamethasone administration is superior in extending the effects of a brachial plexus nerve block.

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Detailed Description

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Conditions

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Post Operative Pain Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: Block with Ropivacaine + Dexamethasone

Before surgery an ultrasound guided supraclavicular block with ropivacaine and 4 mg of dexamethasone will be administered

Group Type ACTIVE_COMPARATOR

Dexamethasone 4mg

Intervention Type DRUG

4 mg of Dexamethasone will be given before surgery

Ropivacaine

Intervention Type DRUG

Ultrasound guided supraclavicular block with ropivacaine will be given to patients before surgery

Group 2: Ropivacaine Block + IV Dexamethasone

Before surgery an ultrasound guided supraclavicular block with ropivacaine will be administered and patients will receive dexamethasone intravenously

Group Type ACTIVE_COMPARATOR

Dexamethasone 4mg

Intervention Type DRUG

4 mg of Dexamethasone will be given before surgery

Ropivacaine

Intervention Type DRUG

Ultrasound guided supraclavicular block with ropivacaine will be given to patients before surgery

Interventions

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Dexamethasone 4mg

4 mg of Dexamethasone will be given before surgery

Intervention Type DRUG

Ropivacaine

Ultrasound guided supraclavicular block with ropivacaine will be given to patients before surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients over the age of 18 undergoing open reduction and internal fixation of a distal radius fracture less than 3 weeks from injury with a volar plate technique
* American Society of Anesthesiologists (ASA) levels 1 through 3 at time of surgery
* Opioid naïve patients

Exclusion Criteria

* History of Drug/opioid/alcohol abuse
* Polytrauma patients
* History of inflammatory disorder, infection, dementia, psychiatric/neurological disorder, relevant drug/local anesthesia allergy, relevant chronic upper extremity pain (RSD, fibromyalgia, neuralgia, etc)
* Excessive BMI
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes