Randomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation

Randomized Controlled Trial Assessing the Effect of Intraoperative Dexamethasone in the Management of Postoperative Analgesia and Stiffness After Distal Radius Fixation

The study is designed to assess the use of intraoperative dexamethasone on postoperative analgesia and stiffness after open reduction and internal fixation of distal radius fractures. The idea is that the dexamethasone will aid in reducing postoperative swelling which will then improve pain control as well as overall function.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Drug: Dexamethasone; Other: No dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Willingness to comply with study procedures and
• Male or female greater than 18 years old
• American Society of Anesthesia class I/II/III
• Ability to take oral medicine in order to assess opioid regimen postop
• Distal radius open reduction and internal fixation surgery with single incision and volar plate
• Ability to consent for and receive a preoperative upper extremity nerve block by anesthesia

Exclusion Criteria:

• Chronic opioid users
• Prescriptions for selective-serotonin reuptake inhibitors, gabapentin, duloxetine within 3 days of surgery
• History of diabetes and A1C > 8
• Systemic glucocorticoids within 1 month of study enrollment
• Inability to take ibuprofen or acetaminophen due to allergy or condition
• History of hepatitis
• Pregnancy or lactation
• Allergic to opioids
• Known allergic reactions to components of IV dexamethasone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; Patient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation	Drug: Dexamethasone; Intraoperative intravenous dexamethasone
Placebo Comparator: No dexamethasone; Patient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation	Other: No dexamethasone; No intraoperative intravenous dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient rated wrist evaluation	15-item questionnaire designed to measure wrist pain and disability in activities of daily living. PWRE will be assessed at multiple time point to assess for change in the score. The higher the score, the more function exhibited.	48 hours, 1 week, 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Finger-to-palm distance	Objective measure to quantify stiffness. This is measured by measuring the distance from the tip of the third finger to the palm during attempted creation of a fist. FTP will be measured at multiple time points to assess for change.	48 hours, 1 week, 2 weeks
Visual analog scale	Validated, subjective measure for pain. Measured on a 10 point scale, 0 being no pain and 10 being maximum pain. VAS will be evaluated at multiple time points to assess for change.	48 hours, 1 week, 2 weeks
Total opioid consumption	Measuring total opioid consumption postoperatively. This will be measured by self reported mechanism. Assessed at multiple time points to assess for change.	48 hours, 1 week, 2 weeks

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Radius Fractures; Wrist Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 21-0069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

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