Distal Radius FractureEarly Phase 1NCT04889547
Randomized Controlled Trial Assessing the Effect of Dexamethasone on Postoperative Function After Distal Radius Fixation
A Early Phase 1 study testing Dexamethasone and No dexamethasone in people with Distal Radius Fracture, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Dexamethasone and No dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2021to 1 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy or lactation
- Allergic to opioids
- Known allergic reactions to components of IV dexamethasone
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
Official title: Randomized Controlled Trial Assessing the Effect of Intraoperative Dexamethasone in the Management of Postoperative Analgesia and Stiffness 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Dexamethasone, No dexamethasone
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Intraoperative intravenous dexamethasone
No dexamethasoneOther
No intraoperative intravenous dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Patient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation Receives: Drug: Dexamethasone |
| No dexamethasone | Placebo comparator | Patient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation Receives: Other: No dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rated wrist evaluation
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.
Measured: 48 hours, 1 week, 2 weeks
Secondary outcomes (3)
Finger-to-palm distance
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.
Measured: 48 hours, 1 week, 2 weeks
Visual analog scale
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.
Measured: 48 hours, 1 week, 2 weeks
Total opioid consumption
Measuring total opioid consumption postoperatively. This will be measured by self reported mechanism. Assessed at multiple time points to assess for change.
Measured: 48 hours, 1 week, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start10 Jul 2021
- Primary completion1 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889547
- Sponsor's protocol ID
- 21-0069
- Status last verified
- Oct 2023
- First submitted
- 5 Apr 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Assessing the Effect of Intraoperative Dexamethasone in the Management of Postoperative Analgesia and Stiffness After Distal Radius Fixation
- ClinicalTrials.gov ID
- NCT04889547
- Acronym / sponsor ID
- 21-0069
- Conditions
- Distal Radius Fracture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasonePatient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation |
| No dexamethasone | Placebo comparator | Other: No dexamethasonePatient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneIntraoperative intravenous dexamethasone | Drug | Dexamethasone |
| No dexamethasoneNo intraoperative intravenous dexamethasone | Other | No dexamethasone |
Primary outcome
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.
3 secondary outcomes
Finger-to-palm distance
Time frame: 48 hours, 1 week, 2 weeks
Visual analog scale
Time frame: 48 hours, 1 week, 2 weeks
Total opioid consumption
Time frame: 48 hours, 1 week, 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone and No dexamethasone in people with Distal Radius Fracture, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rated wrist evaluation (time frame: 48 hours, 1 week, 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.