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NCT Number: NCT04889547

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Intraoperative intravenous dexamethasone

No Dexamethasone

Other

No intraoperative intravenous dexamethasone

Primary outcomes

  1. Patient rated wrist evaluation

    Time frame: 48 hours, 1 week, 2 weeks

    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.

Secondary outcomes

  1. Finger-to-palm distance

    Time frame: 48 hours, 1 week, 2 weeks

    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.

  2. Visual analog scale

    Time frame: 48 hours, 1 week, 2 weeks

    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.

  3. Total opioid consumption

    Time frame: 48 hours, 1 week, 2 weeks

    Measuring total opioid consumption postoperatively. This will be measured by self reported mechanism. Assessed at multiple time points to assess for change.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 17, 2021
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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