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

Sponsor
Northwell Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04889547
Collaborator
(none)
75
Enrollment
2
Arms
9
Anticipated Duration (Months)

Study Details

Study Description

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 the dexamethasone will aid in reducing postoperative swelling which will then improve pain control as well as overall function.

Condition or DiseaseIntervention/TreatmentPhase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial Assessing the Effect of Intraoperative Dexamethasone in the Management of Postoperative Analgesia and Stiffness After Distal Radius Fixation
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Dexamethasone

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

Drug: Dexamethasone
Intraoperative intravenous dexamethasone

Placebo Comparator: No dexamethasone

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

Other: No dexamethasone
No intraoperative intravenous dexamethasone

Outcome Measures

Primary Outcome Measures

  1. Patient rated wrist evaluation [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 Outcome Measures

  1. Finger-to-palm distance [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwell Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northwell Health
ClinicalTrials.gov Identifier:
NCT04889547
Other Study ID Numbers:
  • Northwell Health
First Posted:
May 17, 2021
Last Update Posted:
May 17, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2021