Hematoma Block Versus Bier Block for Closed Fracture Reduction

Distal Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05086224
• Other study ID #: 131997
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: July 15, 2021
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Fractures, Closed
• Hematoma
• Radius Fractures
• Wrist Fractures

Intervention

Drug:
• Hematoma Local Anesthetic Block Procedure with 1% Lidocaine
Inject anesthetic into the hematoma site, 20 mL of 1% lidocaine without epinephrine.
• Bier Anesthetic Block Procedure with 1% Lidocaine
Intravenous anesthetic infusion, a maximum lidocaine dosing of 3 mg/kg.

Locations

Country	Name	City	State
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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