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Distal Radius FracturesEarly Phase 1NCT05086224

Hematoma Block Versus Bier Block for Closed Fracture Reduction

A Early Phase 1 study testing Hematoma Local Anesthetic Block Procedure with 1% Lidocaine and Bier Anesthetic Block Procedure with 1% Lidocaine in people with Distal Radius Fractures, run by University of Utah at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The investigators objective of this study is to evaluate the effectiveness of hematoma block versus intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Distal Radius Fractures
What is being tested?
Hematoma Local Anesthetic Block Procedure with 1% Lidocaine and Bier Anesthetic Block Procedure with 1% Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
15 Jul 2021to Jul 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (age 18+ years of age) with a closed distal radius.
  • Eligible patients will be those who require a closed reduction for a displaced fracture.
  • Any distal radius that falls outside of normal anatomic parameters will require reduction.
  • Normal anatomic parameters include radial inclination: 22°; mean, 19° to 29°, radial height: 11 to 12 mm, and volar tilt 11°; mean,11° to 14.5°.
  • Patients presenting with intact neurovascular exam will be included (sensation intact about ulnar, median, and radial nerve distributions with an intact radial pulse.

Who cannot join

  • Not able to provide informed consent (intubated or cognitively impaired).
  • Member of vulnerable populations such as non-English speaking and incarcerated patients.
  • Pregnant or lactating women.
  • Have open fractures or altered neurovascular exams.
  • Have any confounding injures such as an associated dislocation or subluxation of the carpus or patients who have a concomitant upper extremity injury requiring surgery.
  • Patients who will obtain follow-up elsewhere (as they will not be able to be studied longitudinally.
  • Patients who have are unable to tolerate the tourniquet pressure while awake or in whom IV access is unable to be obtained in the correct hand will be excluded from the bier block arm of the study.
  • Patients with skin compromise or breakdown or active infection overlying fracture site will be excluded from the hematoma block arm.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah Orthopaedic Center

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: Hematoma Block vs. Bier Block: Which is More Effective for Closed Fracture Reduction?

The investigators objective of this study is to evaluate the effectiveness of hematoma block versus intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures.

Read the detailed description

The investigators objective of this study is to evaluate the effectiveness of hematoma block compared to intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures. Distal radius fractures represent one of the most commonly treated skeletal injuries in the US. Achieving a fracture reduction that restores anatomy of the distal radius is of paramount importance. Reductions that re-establish anatomical parameters can prevent a patient from requiring operative intervention for the fracture, eliminating the risks as well as costs that are inherent in undergoing surgery.

Intravenous regional anesthesia (IVRA) or 'Bier block' is an effective technique used to provide anesthesia to the distal extremity. IVRA involves venous infiltration of a local anesthetic with concomitant use of a tourniquet to restrict infiltration solely to the intended extremity. Hematoma block involves local infiltration of local anesthetic directly into the site of a hematoma to provide analgesia. Both IVRA and hematoma blocks can be used to provide analgesia during a variety of procedures including fracture manipulation and reduction, but there is a paucity of data regarding the possible superiority of one means of analgesia.

To date, only a few comparative studies has been performed regarding the use of these two analgesia methods. Numerous investigators have conducted studies evaluating these two methods of analgesia; but these studies were of relatively poor quality, are older (prior to 1995) or did not individually look at all radiographic parameters that are important to orthopedic surgical providers when determining if a distal radius fracture needs surgery, particularly ulnar variance and articular step-off or gapping.

The investigators institution is one of the few in the country that utilizes bier blocks, performed by orthopedic residents, for most closed reductions in the emergency department. This quality makes the investigators institution uniquely qualified and motivated to perform the proposed investigation.

Concerns regarding the implementation of the Bier block surround its' safety profile, including possible increased risk of carpal tunnel, and in more severe cases, seizures or cardiac arrest. Despite the frequency with which investigators manage distal radius fractures, our experience has been that the major complication profile of this technique is minimal. Other studies have supported the notion that catastrophic complications are rare and the most common "complication" is tourniquet pain. These studies are limited by their nature in that anesthesia or emergency medicine providers performed the Bier blocks, while in most instances having the orthopaedic provider perform the block as well as the reduction is more efficient.

The standard of care for most institutions is to perform a closed reduction of distal radius fracture with general conscious sedation or a local hematoma block. The investigators standard of care is to perform Bier blocks as the investigators believe it results in a more anatomic reduction, due to better analgesia and patient comfort during the procedure, thus allowing for more aggressive yet tolerable manipulation. Improved reduction quality may result in less conversion from closed management in a cast to surgical intervention which has direct impact on the patients being treated as well as on the health care system at large. The investigators hypothesis is that there is both better analgesia and fracture reduction with use of Bier block compared to hematoma block.

Being tested
Hematoma Local Anesthetic Block Procedure with 1% Lidocaine, Bier Anesthetic Block Procedure with 1% Lidocaine
Keywords
Distal radius fractures, Hematoma block, Bier block, Pain
Medical subject headings
Wrist Fractures, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hematoma Local Anesthetic Block Procedure with 1% LidocaineDrug

    Also called Lignocaine, Xylocaine, Ztlido (lidocaine)

    Inject anesthetic into the hematoma site, 20 mL of 1% lidocaine without epinephrine.

  • Bier Anesthetic Block Procedure with 1% LidocaineDrug

    Also called Lignocaine, Xylocaine, Ztlido (lidocaine)

    Intravenous anesthetic infusion, a maximum lidocaine dosing of 3 mg/kg.

Study groups in NCT05086224
Study groupRoleWhat they receive
Hematoma BlockOtherInject 20 mL of 1% lidocaine without epinephrine into the hematoma site.
Receives: Drug: Hematoma Local Anesthetic Block Procedure with 1% Lidocaine
Bier BlockOtherIntravenous administration a maximum lidocaine dose of 3 mg/kg.
Receives: Drug: Bier Anesthetic Block Procedure with 1% Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: Prior to fracture manipulation

  2. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: During anesthetic injection or infusion, an average of 10 minutes.

  3. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: During fracture manipulation, an average of 10 minutes.

  4. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: 30 minutes following fracture manipulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2021
  2. Study start15 Jul 2021
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05086224
Sponsor's protocol ID
131997
Status last verified
Apr 2026
First submitted
16 Sep 2021
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Hematoma Local Anesthetic Block Procedure with 1% Lidocaine and Bier Anesthetic Block Procedure with 1% Lidocaine in people with Distal Radius Fractures, run by University of Utah 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Visual Analog Scale (VAS) pain (time frame: Prior to fracture manipulation). The study lists 4 primary outcomes in all. 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 Apr 2026.

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