Low Dose Dexamethasone for Distal Radius Fractures

Efficacy of Direct Versus Peripheral Low-Dose Adjuvant Dexamethasone on Duration and Rebound Pain in Regional Anesthesia for Distal Radius Fracture Fixation: A Prospective Randomized Controlled Blinded Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Distal Radius Fracture; Post Operative Pain
• Intervention / Treatment: Drug: Dexamethasone 4mg; Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1: Block with Ropivacaine + Dexamethasone; Before surgery an ultrasound guided supraclavicular block with ropivacaine and 4 mg of dexamethasone will be administered	Drug: Dexamethasone 4mg; 4 mg of Dexamethasone will be given before surgery; Drug: Ropivacaine; Ultrasound guided supraclavicular block with ropivacaine will be given to patients before surgery
ACTIVE_COMPARATOR: Group 2: Ropivacaine Block + IV Dexamethasone; Before surgery an ultrasound guided supraclavicular block with ropivacaine will be administered and patients will receive dexamethasone intravenously	Drug: Dexamethasone 4mg; 4 mg of Dexamethasone will be given before surgery; Drug: Ropivacaine; Ultrasound guided supraclavicular block with ropivacaine will be given to patients before surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 10, 2022
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (ACTUAL): March 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Arm Injuries; Forearm Injuries; Pain, Postoperative; Fractures, Bone; Radius Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Ropivacaine
• Other Study ID Numbers: MWAN22D.110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No