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

NCT ID: NCT04889547

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-10

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Dexamethasone

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Intraoperative intravenous dexamethasone

No dexamethasone

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

Group Type PLACEBO_COMPARATOR

No dexamethasone

Intervention Type OTHER

No intraoperative intravenous dexamethasone

Interventions

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Dexamethasone

Intraoperative intravenous dexamethasone

Intervention Type DRUG

No dexamethasone

No intraoperative intravenous dexamethasone

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status

Countries

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United States

Other Identifiers

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21-0069

Identifier Type: -

Identifier Source: org_study_id

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