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

Northwell Health

Status and phase: Completed; Early Phase 1

Conditions: Distal Radius Fracture

Treatments: Drug: Dexamethasone; Other: No dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04889547

21-0069

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

Patient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation

Treatment:

Drug: Dexamethasone

No dexamethasone

Placebo Comparator group

Description:

Patient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation

Treatment:

Other: No dexamethasone