Hematoma Block Versus Bier Block for Closed Fracture Reduction

March 12, 2024 updated by: Lucas Marchand, University of Utah

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopaedic Center

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

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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
Intervention / Treatment
Other: Hematoma Block
Inject 20 mL of 1% lidocaine without epinephrine into the hematoma site.
Drug: Hematoma Local Anesthetic Block Procedure with 1% Lidocaine
Inject anesthetic into the hematoma site, 20 mL of 1% lidocaine without epinephrine.
Other Names:
  • Lignocaine, Xylocaine, Ztlido (lidocaine)
Other: Bier Block
Intravenous administration a maximum lidocaine dose of 3 mg/kg.
Drug: Bier Anesthetic Block Procedure with 1% Lidocaine
Intravenous anesthetic infusion, a maximum lidocaine dosing of 3 mg/kg.
Other Names:
  • Lignocaine, Xylocaine, Ztlido (lidocaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) pain
Time Frame: Prior to fracture manipulation
VAS pain score (0 no pain - 10 severe pain)
Prior to fracture manipulation
Visual Analog Scale (VAS) pain
Time Frame: During anesthetic injection or infusion, an average of 10 minutes.
VAS pain score (0 no pain - 10 severe pain)
During anesthetic injection or infusion, an average of 10 minutes.
Visual Analog Scale (VAS) pain
Time Frame: During fracture manipulation, an average of 10 minutes.
VAS pain score (0 no pain - 10 severe pain)
During fracture manipulation, an average of 10 minutes.
Visual Analog Scale (VAS) pain
Time Frame: 30 minutes following fracture manipulation
VAS pain score (0 no pain - 10 severe pain)
30 minutes following fracture manipulation

Collaborators and Investigators

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

Sponsor

University of Utah

Investigators

  • Principal Investigator: Lucas Marchand, MD, University of Utah Orthopaedics

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)

July 15, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131997

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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