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

21-0069

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.

2021-07-10

2023-07-01

2023-09-01

Completed

Early phase I

70

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

2023-10-23