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

Early Phase 1CompletedNCT04889547

Northwell Health70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Distal Radius Fracture

Interventions

DexamethasoneDRUG

Intraoperative intravenous dexamethasone

No dexamethasoneOTHER

No intraoperative intravenous dexamethasone

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

North Shore University Hospital

Manhasset, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 48 hours, 1 week, 2 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 48 hours, 1 week, 2 weeks

Data from ClinicalTrials.gov

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