Randomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jul 2021
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedStudy Start
First participant enrolled
July 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedOctober 23, 2023
October 1, 2023
2 years
April 5, 2021
October 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Finger-to-palm distance
48 hours, 1 week, 2 weeks
Visual analog scale
48 hours, 1 week, 2 weeks
Total opioid consumption
48 hours, 1 week, 2 weeks
Study Arms (2)
Dexamethasone
EXPERIMENTALPatient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation
No dexamethasone
PLACEBO COMPARATORPatient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
North Shore University Hospital
Manhasset, New York, 11030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2021
First Posted
May 17, 2021
Study Start
July 10, 2021
Primary Completion
July 1, 2023
Study Completion
September 1, 2023
Last Updated
October 23, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share