Hematoma vs Bier Block for Broken Bones

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

Disqualifiers: Pregnant, Lactating, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of anesthesia for treating broken wrist bones to determine which is more effective. One method involves injecting a painkiller directly into the injury site (hematoma block), while the other uses an IV to numb the arm (Bier anesthetic block). Individuals with a broken wrist bone that is misaligned and requires repositioning may be suitable for this study. Participants must have normal nerve function in the affected arm. The trial aims to make setting broken bones more comfortable and effective. As an Early Phase 1 trial, this research focuses on understanding how these anesthesia methods work in people, offering participants a chance to contribute to groundbreaking medical knowledge.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that using a hematoma block with 1% lidocaine was very safe and effective for treating broken bones like wrist fractures. This method is often preferred over general anesthesia due to its lower risk and effective pain relief.

For the Bier block, which also uses 1% lidocaine, research has shown that side effects are rare. Some patients experienced minor issues like low blood pressure or a slow heart rate, but these were temporary and required no further medical treatment.

Both treatments use lidocaine, a common local pain reliever, and are generally well-tolerated in medical practice. The current study is in an early phase, focusing mainly on safety, so any issues will be closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial comparing the Hematoma Block and the Bier Block for pain relief in broken bones because these methods might offer quicker, localized pain management compared to standard systemic painkillers like opioids. The Hematoma Block involves directly injecting lidocaine into the injury site, potentially providing fast and targeted relief with minimal systemic effects. On the other hand, the Bier Block uses intravenous lidocaine, which could offer another effective, yet distinct, method of localized anesthesia without the need for general anesthesia. Both methods aim to provide effective pain control while potentially reducing reliance on more addictive or riskier medications.

What evidence suggests that this trial's treatments could be effective for distal radius fractures?

This trial will compare the effectiveness of two pain relief methods for bone fracture treatment: the hematoma block and the Bier block. Research has shown that both the hematoma block, which involves injecting 20 mL of 1% lidocaine into the hematoma site, and the Bier block, which involves intravenous administration of lidocaine, effectively relieve pain. Studies have found that the hematoma block is a safe and effective option for managing pain when setting broken bones, especially in the wrist. Similarly, the Bier block is a reliable method for pain management, particularly in outpatient settings. Both methods use 1% lidocaine, a common numbing medicine, to help minimize pain during treatment. ^{1 5 6 7 8}

Who Is on the Research Team?

Lucas Marchand, MD

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a closed distal radius fracture needing reduction, who have normal sensation and pulse in the affected arm. Excluded are those unable to consent, non-English speakers, incarcerated individuals, pregnant or lactating women, patients with skin issues at the fracture site or open fractures.

Inclusion Criteria

My wrist bone is out of place and needs to be corrected.

I can feel and move my hands normally, and my wrist pulse is good.

I need a procedure to fix a bone fracture without surgery.

Exclusion Criteria

I am unable to give informed consent due to being intubated or having cognitive impairments.

Pregnant or lactating women

I do not have skin issues or infections over my fracture.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a hematoma block or a Bier block for closed reduction of distal radius fractures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain and reduction quality after the procedure

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bier Anesthetic Block Procedure with 1% Lidocaine
• Hematoma Local Anesthetic Block Procedure with 1% Lidocaine

Trial Overview The study compares two types of anesthesia during wrist fracture repair: Hematoma Block using local anesthetic directly at the injury site and Bier Block which involves anesthetizing the entire arm by injecting into a vein.

How Is the Trial Designed?

Group I: Hematoma Block Experimental Treatment 1 Intervention

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

Group II: Bier Block Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Hematoma blocks are generally a safe and effective method for providing anesthesia during the treatment of displaced distal radius fractures, allowing for closed reduction.

However, there is a rare risk of systemic neurologic complications from local anesthetics, as demonstrated in a case where a patient experienced such complications after receiving a hematoma block with 20 mL of 1% lidocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Hematoma Block in the Wrist for a Displaced Distal Radius Fracture Induces Systemic Neurological Symptoms: A Case Report. Burch, CS., Stevens, CG.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17324303/

Safety and Effectiveness of Intravenous Regional ... Bier block anesthesia is a safe, effective and reliable technique in an outpatient primary care setting. This technique is a useful modality for physicians ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05086224

Hematoma Block Versus Bier Block for Closed Fracture ... The investigators objective of this study is to evaluate the effectiveness of hematoma block compared to intravenous regional anesthesia (Bier ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9796829/

Periosteal block versus intravenous regional anesthesia for ... We compare periosteal block and intravenous regional anesthesia (IVRA) as anesthetic techniques for reduction of distal radius fractures.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/0020138386903311

Bier's block—an improved technique A simple modification to the method of regional anaesthesia known as Bier's block is presented. This was applied to patients with Colles' fractures.

5. researchopenworld.com researchopenworld.com/bier-block-regional-anesthesia-versus-conscious-sedation-in-pediatric-forearm-fracture-management-clinical-outcomes-and-costs/

Bier Block Regional Anesthesia versus Conscious ... This method of anesthesia has a long historical record of safety and efficacy, and does not require the patient to have an empty stomach as is ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22627706/

Is lidocaine Bier's block safe? Complications were reported in 39 cases; transient hypotension/vasovagal episodes and transient mild bradycardia were most frequent. No patients required any ...

7. caep.ca caep.ca/periodicals/Volume_8_Issue_4/Vol_8_Issue_4_Page_247_-_250_Mohr.pdf

Safety and effectiveness of intravenous regional anesthesia ... Adverse events were recorded in 9 cases (0.50%, 95% confidence interval. 0.23%–0.94%): 1 case of medication error (0.06%); 3 of improper cuff inflation (0.17%); ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S235245291830121X

Intravenous Regional Anesthesia: A Historical Overview ... Prilocaine and lidocaine both are effective for IVRA and are routinely applied in daily practice. •. Prilocaine seems to be safe if applied in adequate dosages.