NCT07268547

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
19mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

December 9, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

November 18, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

wrist fracturefracturenerve block

Outcome Measures

Primary Outcomes (1)

  • Pain levels comparison

    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 Outcomes (3)

  • Amount of opioid medication needed to control pain.

    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will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.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.

    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

    From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.

Study Arms (3)

Supracondylar radial nerve blocks

EXPERIMENTAL

Lidocaine injection given near the radial never under ultrasound guidance

Procedure: Supracondylar radial nerve block

Hematoma blocks

EXPERIMENTAL

Injecting analgesia into the hematoma that forms surrounding the wrist fracture

Procedure: Hematoma block

Combination of supracondylar radial nerve block and hematoma block

EXPERIMENTAL

Supracondylar radial nerve block given first followed by hematoma block

Procedure: Combination of blocks

Interventions

Supracondylar radial nerve blocks given at the radial nerve not as the same location of the fracture site, prior to fracture reduction.

Supracondylar radial nerve blocks

Injection of analgesia into the hematoma that forms surrounding the wrist fracture.

Hematoma blocks

Supracondylar radial nerve block given first, followed by hematoma block, before fracture reduction.

Combination of supracondylar radial nerve block and hematoma block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Related Publications (10)

  • Tseng PT, Leu TH, Chen YW, Chen YP. Hematoma block or procedural sedation and analgesia, which is the most effective method of anesthesia in reduction of displaced distal radius fracture? J Orthop Surg Res. 2018 Mar 27;13(1):62. doi: 10.1186/s13018-018-0772-7.

    PMID: 29580286BACKGROUND
  • Siebelt M, Hartholt KA, van Winden DFM, Boot F, Papathanasiou D, Verdouw BC, de Vries MR, Mathijssen NM, Kraan GA. Ultrasound-Guided Nerve Blocks as Analgesia for Nonoperative Management of Distal Radius Fractures-Two Consecutive Randomized Controlled Trials. J Orthop Trauma. 2019 Apr;33(4):e124-e130. doi: 10.1097/BOT.0000000000001388.

    PMID: 30893220BACKGROUND
  • Oakley B, Busby C, Kulkarni S, Arnold SJ, Kulkarni SS, Ollivere BJ. Manipulation of distal radius fractures: a comparison of Bier's block vs haematoma block. Ann R Coll Surg Engl. 2023 May;105(5):434-440. doi: 10.1308/rcsann.2022.0116. Epub 2022 Oct 14.

    PMID: 36239973BACKGROUND
  • Maia GAS, Cunha JC, Feijo CQ, Leal DM, Moreira JJ, Herrero CFPDS. Radial Nerve Supracondylar Block Versus Fracture Hematoma Block. Comparison of Their Efficacy in Cases of Fractures of the Distal Third of the Radius. Rev Bras Ortop (Sao Paulo). 2023 Aug 30;58(4):e557-e562. doi: 10.1055/s-0043-1768623. eCollection 2023 Aug.

    PMID: 37663190BACKGROUND
  • Handoll HH, Madhok R, Dodds C. Anaesthesia for treating distal radial fracture in adults. Cochrane Database Syst Rev. 2002;2002(3):CD003320. doi: 10.1002/14651858.CD003320.

    PMID: 12137688BACKGROUND
  • Haley CB, Beauchesne AR, Fox JC, Nelson AM. Block Time: A Multispecialty Systematic Review of Efficacy and Safety of Ultrasound-guided Upper Extremity Nerve Blocks. West J Emerg Med. 2023 Jun 30;24(4):774-785. doi: 10.5811/westjem.56058.

    PMID: 37527380BACKGROUND
  • Gottlieb M, Cosby K. Ultrasound-guided hematoma block for distal radial and ulnar fractures. J Emerg Med. 2015 Mar;48(3):310-2. doi: 10.1016/j.jemermed.2014.09.063. Epub 2014 Dec 9.

    PMID: 25497895BACKGROUND
  • Martinez-Arboleda JJ, Moreno M, Diaz-Solorzano JP, Mejia-Grueso A. Ultrasound-guided supracondylar radial nerve block for closed reduction of a distal radius fracture in the emergency department: Case report. Trauma Case Rep. 2024 Sep 25;54:101116. doi: 10.1016/j.tcr.2024.101116. eCollection 2024 Dec.

    PMID: 39399762BACKGROUND
  • Che Daud AZ, Mohd Nayan NA, Ahmad A, Alrashdi M, Kadar M, Mohd Poot EF. Distal radius fracture rehabilitation: A bibliometric and scoping review. J Hand Ther. 2026 Jan-Mar;39(1):120-132. doi: 10.1016/j.jht.2025.05.016. Epub 2025 Jul 4.

    PMID: 40615307BACKGROUND
  • Abbasi S, Garjani N, Mahshidfar B, Farsi D, Mofidi M, Hafezimoghadam P, Rezai M, Javan A. Comparative Study of Radial and Median Nerve Blocks with Hematoma Block under Ultrasound Guide in Distal Radius Fracture Reduction: A Randomized Clinical Trial. Med J Islam Repub Iran. 2023 Oct 23;37:113. doi: 10.47176/mjiri.37.113. eCollection 2023.

    PMID: 38145179BACKGROUND

MeSH Terms

Conditions

Wrist FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and Injuries

Study Officials

  • Aaron Grossberg, DO

    Sarasota Memorial Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 lowering pain in people with a broken wrist (distal radius fracture). We want to find out which method provides better pain relief after the injury and during treatment in the emergency room. Each of these methods is a different standard procedure for pain control prior to wrist fracture reduction.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 5, 2025

Study Start

December 9, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations