Low Dose Dexamethasone for Distal Radius Fractures

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05274113
• Other study ID #: MWAN22D.110
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: March 10, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2022
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Pain, Postoperative
• Post Operative Pain
• Radius Fractures

Intervention

Drug:
• Dexamethasone 4mg
4 mg of Dexamethasone will be given before surgery
• Ropivacaine
Ultrasound guided supraclavicular block with ropivacaine will be given to patients before surgery

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

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