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

Study Overview
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Brief Summary
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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.

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

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Drug: Dexamethasone
* Other: No dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Patient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation | Drug: Dexamethasone<br>* Intraoperative intravenous dexamethasone<br>|
| Placebo Comparator: No dexamethasone<br>Patient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation | Other: No dexamethasone<br>* No intraoperative intravenous dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |