Randomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
Sponsors and Collaborators
- Northwell Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-0069