Low Dose Dexamethasone for Distal Radius Fractures

Rothman Institute Orthopaedics

Status and phase: Unknown; Phase 3

Conditions: Distal Radius Fracture; Post Operative Pain

Treatments: Drug: Dexamethasone 4mg; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05274113

MWAN22D.110

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Group 1: Block with Ropivacaine + Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Dexamethasone 4mg

Group 2: Ropivacaine Block + IV Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Dexamethasone 4mg