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Hematoma Block Versus Bier Block for Closed Fracture Reduction

Primary Purpose

Distal Radius Fractures

Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hematoma Local Anesthetic Block Procedure with 1% Lidocaine
Bier Anesthetic Block Procedure with 1% Lidocaine
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fractures focused on measuring Distal radius fractures, Hematoma block, Bier block, Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Utah Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Hematoma Block

Bier Block

Arm Description

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

Intravenous administration a maximum lidocaine dose of 3 mg/kg.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)

Secondary Outcome Measures

Full Information

First Posted
September 16, 2021
Last Updated
August 6, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05086224
Brief Title
Hematoma Block Versus Bier Block for Closed Fracture Reduction
Official Title
Hematoma Block vs. Bier Block: Which is More Effective for Closed Fracture Reduction?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
Distal radius fractures, Hematoma block, Bier block, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hematoma Block
Arm Type
Other
Arm Description
Inject 20 mL of 1% lidocaine without epinephrine into the hematoma site.
Arm Title
Bier Block
Arm Type
Other
Arm Description
Intravenous administration a maximum lidocaine dose of 3 mg/kg.
Intervention Type
Drug
Intervention Name(s)
Hematoma Local Anesthetic Block Procedure with 1% Lidocaine
Other Intervention Name(s)
Lignocaine, Xylocaine, Ztlido (lidocaine)
Intervention Description
Inject anesthetic into the hematoma site, 20 mL of 1% lidocaine without epinephrine.
Intervention Type
Drug
Intervention Name(s)
Bier Anesthetic Block Procedure with 1% Lidocaine
Other Intervention Name(s)
Lignocaine, Xylocaine, Ztlido (lidocaine)
Intervention Description
Intravenous anesthetic infusion, a maximum lidocaine dosing of 3 mg/kg.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
Prior to fracture manipulation
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
During anesthetic injection or infusion, an average of 10 minutes.
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
During fracture manipulation, an average of 10 minutes.
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
30 minutes following fracture manipulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas Marchand, MD
Organizational Affiliation
University of Utah Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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Hematoma Block Versus Bier Block for Closed Fracture Reduction

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