Back to resultsRandomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation
Primary Purpose
Distal Radius Fracture
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
No dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture
Eligibility Criteria
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
Sites / Locations
- North Shore University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone
No dexamethasone
Arm Description
Patient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation
Patient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04889547
Brief Title
Randomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation
Official Title
Randomized Controlled Trial Assessing the Effect of Intraoperative Dexamethasone in the Management of Postoperative Analgesia and Stiffness After Distal Radius Fixation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Patient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation
Arm Title
No dexamethasone
Arm Type
Placebo Comparator
Arm Description
Patient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Intraoperative intravenous dexamethasone
Intervention Type
Other
Intervention Name(s)
No dexamethasone
Intervention Description
No intraoperative intravenous dexamethasone
Primary Outcome Measure Information:
Title
Patient rated wrist evaluation
Description
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.
Time Frame
48 hours, 1 week, 2 weeks
Secondary Outcome Measure Information:
Title
Finger-to-palm distance
Description
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.
Time Frame
48 hours, 1 week, 2 weeks
Title
Visual analog scale
Description
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.
Time Frame
48 hours, 1 week, 2 weeks
Title
Total opioid consumption
Description
Measuring total opioid consumption postoperatively. This will be measured by self reported mechanism. Assessed at multiple time points to assess for change.
Time Frame
48 hours, 1 week, 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Randomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation
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