Wrist Reduction Intervention: Supracondylar Technique for Radial Nerve Block vs. Hematoma Block (WRIST Block Study)

December 11, 2025 updated by: Aaron Grossberg, Sarasota Memorial Health Care System
The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for reducing pain in people with a broken wrist (distal radius fracture). This is being done to find out which method provides better pain relief after the injury and during treatment in the emergency room.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is testing different ways to provide pain relief before reducing a broken wrist. Participants will receive one of three techniques: (1) a nerve block where a doctor injects lidocaine near the radial nerve under ultrasound guidance; (2) a hematoma block where a doctor injects lidocaine into the area where the bone broke; or (3) both the nerve block and the hematoma block. Patients will be asked how much pain they feel before the numbing, after the numbing, and after the wrist is reduced.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • Patients admitted to the ECC with a distal radius fracture requiring closed reduction
  • Patient must be willing and able to provide informed consent to the study

Exclusion Criteria:

  • Under 18 years of age
  • Pregnant
  • Prisoner
  • Allergy to lidocaine
  • Patients unable to provide informed consent and/or perform study-related activities
  • Patients undergoing procedural sedation
  • Patients may be excluded at the discretion of the investigator based on their clinical judgment, if the participant no longer meets criteria, and/or if the health or safety of the patient may be impacted by taking part in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supracondylar radial nerve blocks
Lidocaine injection given near the radial never under ultrasound guidance
Procedure: Supracondylar radial nerve block
Supracondylar radial nerve blocks given at the radial nerve not as the same location of the fracture site, prior to fracture reduction.
Experimental: Hematoma blocks
Injecting analgesia into the hematoma that forms surrounding the wrist fracture
Procedure: Hematoma block
Injection of analgesia into the hematoma that forms surrounding the wrist fracture.
Experimental: Combination of supracondylar radial nerve block and hematoma block
Supracondylar radial nerve block given first followed by hematoma block
Procedure: Combination of blocks
Supracondylar radial nerve block given first, followed by hematoma block, before fracture reduction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain levels comparison
Time Frame: Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.

Comparing pain levels among patients who are undergoing a wrist fracture reduction. Measured on a scale of 0-10, 0= no pain to 10= worst pain.

Pain will be measured at (1) baseline, (2) after administering the assigned pain block (s), and after the (3) fracture reduction.
Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amount of opioid medication needed to control pain.
Time Frame: Opioid medication prescribing will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.
The amount of opioid prescribed, if any, will be collected and recorded for comparison during patient's time in emergency room.
Opioid medication prescribing will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.
Number of patients requiring conscious sedation.
Time Frame: Patients will be monitored for need of conscious sedation from baseline, time of enrollment in the study, until discharge from the emergency room, when they are no longer active in the study.
The need for conscious sedation among patients undergoing wrist fracture reduction in emergency care center will be recorded and monitored for comparison between groups.
Patients will be monitored for need of conscious sedation from baseline, time of enrollment in the study, until discharge from the emergency room, when they are no longer active in the study.
Adverse Events Monitoring
Time Frame: From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.
Adverse events associated with any of the blocks that are administered to patients undergoing a wrist fracture reduction in the emergency care center will be identified, monitored, and recorded for reporting.
From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sarasota Memorial Health Care System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aaron Grossberg, DO, Sarasota Memorial Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-MEDI-58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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