Low Dose Dexamethasone for Distal Radius Fractures

Phase 3

• Conditions: Distal Radius Fracture; Post Operative Pain
• Interventions: Drug: Dexamethasone 4mg; Drug: Ropivacaine

• Registration Number: NCT05274113
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study Start: 2022-03-10
• Study First Posted: 2022-03-10
• Last Update Posted: 2022-03-10
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Ropivacaine Block + IV Dexamethasone	Dexamethasone 4mg	Before surgery an ultrasound guided supraclavicular block with ropivacaine will be administered and patients will receive dexamethasone intravenously
Group 1: Block with Ropivacaine + Dexamethasone	Dexamethasone 4mg	Before surgery an ultrasound guided supraclavicular block with ropivacaine and 4 mg of dexamethasone will be administered
Group 1: Block with Ropivacaine + Dexamethasone	Ropivacaine	Before surgery an ultrasound guided supraclavicular block with ropivacaine and 4 mg of dexamethasone will be administered
Group 2: Ropivacaine Block + IV Dexamethasone	Ropivacaine	Before surgery an ultrasound guided supraclavicular block with ropivacaine will be administered and patients will receive dexamethasone intravenously

Primary Outcome Measures

Name	Time	Method
Postoperative pain control	72 hours	Measured using participants Visual Analog Scale (VAS) pain scores
Postoperative pain control #2 questionnaire	72 hours	Measured by asking participants how much medication they take after surgery to help control their pain

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States