Hematoma Block Versus Bier Block for Closed Fracture Reduction

Sponsor

University of Utah (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05086224

Collaborator

(none)

500

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

21.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fractures	Drug: Hematoma Local Anesthetic Block Procedure with 1% Lidocaine Drug: Bier Anesthetic Block Procedure with 1% Lidocaine	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Visual Analog Scale (VAS) pain [Prior to fracture manipulation]
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain [During anesthetic injection or infusion, an average of 10 minutes.]
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain [During fracture manipulation, an average of 10 minutes.]
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain [30 minutes following fracture manipulation]
VAS pain score (0 no pain - 10 severe pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.