Status:

COMPLETED

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

Lead Sponsor:

Northwell Health

Conditions:

Distal Radius Fracture

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 10 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2023

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT04889547

Start Date

July 10 2021

End Date

September 1 2023

Last Update

October 23 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

North Shore University Hospital

Manhasset, New York, United States, 11030