Distal Radius Fracture
Conditions
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.
Interventions
DRUGDexamethasone
Intraoperative intravenous dexamethasone
OTHERNo dexamethasone
No intraoperative intravenous dexamethasone
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient rated wrist evaluation | 48 hours, 1 week, 2 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Finger-to-palm distance | 48 hours, 1 week, 2 weeks | 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 | 48 hours, 1 week, 2 weeks | 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 | 48 hours, 1 week, 2 weeks | Measuring total opioid consumption postoperatively. This will be measured by self reported mechanism. Assessed at multiple time points to assess for change. |
Countries
United States
Outcome results
None listed