115 Participants Needed

Hematoma Block for Wrist Fractures

(Hematoma Block Trial)

NI
BH
Overseen ByBeatrice Hoffmann, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for managing pain during wrist fracture treatment. One group will receive a traditional method where doctors use touch to locate the right spot for a pain block, while the other group will use an ultrasound to guide them. This method is known as an Ultrasound Guided Hematoma Block. The trial aims to determine if using ultrasound enhances pain management effectiveness. Adults who have recently broken their wrist and are not experiencing severe distress or communication issues might be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative pain management research.

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.

What prior data suggests that this method is safe for wrist fracture treatment?

Research has shown that an ultrasound-guided hematoma block is generally safe and well-tolerated. Studies have found it to be a safer option compared to methods like sedation for managing pain in wrist fractures. This technique uses a gel-like substance to numb the area, reducing pain during the treatment of broken wrists. Major side effects have not been commonly reported, making it a potentially safer choice for pain management.12345

Why are researchers excited about this trial?

Researchers are excited about the ultrasound-guided hematoma block for wrist fractures because it offers a more precise and potentially less painful alternative to traditional methods. Unlike the standard hematoma block, which relies on feel and experience to administer, this approach uses ultrasound technology to accurately target the hematoma, potentially improving the effectiveness of the pain relief. This means patients might experience quicker relief with fewer complications, making the treatment more efficient and comfortable.

What evidence suggests that the ultrasound-guided hematoma block is effective for wrist fractures?

This trial will compare two methods of administering pain relief for wrist fractures. Research has shown that using ultrasound to guide pain relief injections, as in the ultrasound-guided hematoma block arm of this trial, effectively manages pain from wrist fractures. Studies have found this method to be a safe and efficient alternative to traditional pain relief methods that don't use imaging, such as the traditional hematoma block arm in this trial. Compared to injections done without guidance, ultrasound ensures correct placement of the pain relief medicine, improving pain relief. Patients have responded well, often needing less additional pain medication. This method also helps avoid complications linked to more invasive procedures.23456

Who Is on the Research Team?

BH

Beatrice Hoffmann, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who come to the emergency department with a distal radius fracture, which is a type of broken bone near the wrist. It's not specified who can't join, but typically those with additional health complications might be excluded.

Inclusion Criteria

I am over 18 and went to the ER for a wrist fracture.

Exclusion Criteria

High acuity/distress per the Attending ED physician
Altered mental status or intoxication
Aphasia, mental retardation, dementia, or insurmountable communication barrier
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either a traditional or ultrasound-guided hematoma block for analgesia in distal radius fracture reduction

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain reduction and safety after the procedure

4 hours

What Are the Treatments Tested in This Trial?

Interventions

  • Ultrasound Guided Hematoma Block
Trial Overview The study aims to compare two methods of pain relief during bone setting: one using an ultrasound guide (a device that helps visualize inside the body) and the traditional method without visual aid.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ultrasound-guided hematoma blockExperimental Treatment1 Intervention
Group II: traditional hematoma blockActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Harvard University

Collaborator

Trials
237
Recruited
588,000+

Published Research Related to This Trial

A case report highlights that an elderly patient experienced a generalized tonic-clonic seizure after receiving a hematoma block with lidocaine and bupivacaine for a distal radius fracture, despite the doses being within recommended limits.
The incident suggests that using a combination of anesthetics in hematoma blocks may increase the risk of neurological complications in elderly patients, indicating the need for precautions and immediate treatment options during such procedures.
Distal Radius Fracture Hematoma Block with Combined Lidocaine and Bupivacaine can induce Seizures while within Therapeutic Window: A Case Report.Dezfuli, B., Edwards, CJ., DeSilva, GL.[2020]
In a study of 110 patients with distal radius fractures, both the cubital nerve block (CNB) and axillary nerve block (ANB) provided significantly better pain relief during various stages of treatment compared to the conventional fracture hematoma block (FHB).
The ANB was particularly effective, resulting in lower pain scores during the block procedure, fracture reduction, and after plaster cast application, even though the physicians performing the blocks had minimal prior experience with ultrasound guidance.
Ultrasound-Guided Nerve Blocks as Analgesia for Nonoperative Management of Distal Radius Fractures-Two Consecutive Randomized Controlled Trials.Siebelt, M., Hartholt, KA., van Winden, DFM., et al.[2020]
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.
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

Ultrasound Guided Hematoma Block in Distal Radius ...This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal ...
Ultrasound Guided Hematoma Block in Distal Radius ...This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with ...
Use and efficacy of haematoma blocks in managing closed ...Hematoma block is a safe, effective and efficient alternative to procedural sedation in the reduction of distal radial fractures by emergency nurse ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/25016389/
Ultrasound-guided hematoma block in distal radial fracture ...Ultrasound guided haematoma block may be a safe and effective alternative to procedural sedation and analgesia.
Hematoma Block for Wrist Fractures (Hematoma Block Trial)The purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal ...
NCT02346929 | Hematoma Block for Distal Radius FractureThe purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal ...
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