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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889547
• Other study ID #: 21-0069
• Status: Completed
• Phase: Early Phase 1
• Start date: July 10, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Radius Fractures
• Wrist Fractures

Intervention

Drug:
• Dexamethasone
Intraoperative intravenous dexamethasone

Other:
• No dexamethasone
No intraoperative intravenous dexamethasone

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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