Low Dose Dexamethasone for Distal Radius Fractures

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05274113
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain; Distal Radius Fracture	Drug: Dexamethasone 4mg; Drug: Ropivacaine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Mar 10, 2022
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Postoperative pain control [72 hours]

   Measured using participants Visual Analog Scale (VAS) pain scores

2. Postoperative pain control #2 questionnaire [72 hours]

   Measured by asking participants how much medication they take after surgery to help control their pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT05274113
• Other Study ID Numbers: MWAN22D.110
• First Posted: Mar 10, 2022
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• 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
• Additional relevant MeSH terms: Pain, Postoperative; Fractures, Bone; Radius Fractures; Dexamethasone; Ropivacaine

Study Results

No Results Posted as of Mar 10, 2022