Low Dose Dexamethasone for Distal Radius Fractures

NCT05274113 | Unknown Phase 3 FDA Drug

• 1 other identifier: MWAN22D.110
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Distal Radius Fracture

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1: Block with Ropivacaine + Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone 4mg; Drug: Ropivacaine

Group 2: Ropivacaine Block + IV Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone 4mg; Drug: Ropivacaine

Interventions

Dexamethasone 4mg DRUG

4 mg of Dexamethasone will be given before surgery

Group 1: Block with Ropivacaine + Dexamethasone; Group 2: Ropivacaine Block + IV Dexamethasone

Ropivacaine DRUG

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

Group 1: Block with Ropivacaine + Dexamethasone; Group 2: Ropivacaine Block + IV Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Wrist Fractures

Interventions

Dexamethasone; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 10, 2022
• Study Start: March 10, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

US (1)