Hematoma Block for Distal Radius Fracture

NCT ID: NCT02346929

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal radius fracture reduction.

Detailed Description

Hematoma blocks are safe and effective in providing analgesia for fracture reduction1-4. They involve injecting lidocaine directly into the fracture line for analgesia. The physician aspirates blood prior to injection to confirm placement in the hematoma created by the fracture. However, the procedure can be technically difficult if the fracture line is difficult to palpate, for example, due to significant swelling or body habitus. Ultrasound has been shown to improve efficacy in other analgesic procedures such as peripheral nerve blocks5 and also in identifying fracture lines6. There have been case reports and case series which have shown the feasibility and effectiveness of ultrasound guided hematoma blocks for analgesia in patients undergoing reduction for distal radius fractures7,8. To our knowledge there are no randomized controlled trials comparing the use of ultrasound guided hematoma blocks versus traditional hematoma blocks in achieving analgesia for distal radius fracture reduction.

In this study, we will determine if ultrasound improves the efficacy of analgesia when performing hematoma blocks for reduction of distal radius fractures.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ultrasound-guided hematoma block

Patients in this arm will receive a bed-side ultrasound guided hematoma block with analgesia (0.25% bupivacaine)

Group Type: EXPERIMENTAL

ultrasound guide

Intervention Type: OTHER

Patients randomized to this arm will have the hematoma block of the distal radial fracture with the guidance of a bedside ultrasound

traditional hematoma block

Patients in this arm will have the hematoma block of the distal radius fracture with no ultrasound for guidance with analgesia (0.25% bupivacaine)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ultrasound guide

Patients randomized to this arm will have the hematoma block of the distal radial fracture with the guidance of a bedside ultrasound

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patient ≥ 18 years old presenting to the emergency department with complaint of distal radius fracture

Exclusion Criteria

• High acuity/distress per the Attending ED physician
• Altered mental status or intoxication
• Aphasia, mental retardation, dementia, or insurmountable communication barrier
• Acute psychiatric illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard University

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Beatrice Hoffmann

ED Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beatrice Hoffmann, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Beatrice Hoffmann, MD

Role: CONTACT

bhoffma2@bidmc.harvard.edu

617-754-2323

Nathan I Shapiro, MD MPH

Role: CONTACT

nshapiro@bidmc.harvard.edu

617-754-2332

Facility Contacts

Beatrice Hoffmann, MD

Role: primary

bhoffma2@bidmc.harvard.edu

617-754-2323

Elinita Rosseto

Role: backup

erosseto@bidmc.harvard.edu

617-754-2332

References

Furia JP, Alioto RJ, Marquardt JD. The efficacy and safety of the hematoma block for fracture reduction in closed, isolated fractures. Orthopedics. 1997 May;20(5):423-6. doi: 10.3928/0147-7447-19970501-11.

Reference Type: BACKGROUND

PMID: 9172249 (View on PubMed)

Alioto RJ, Furia JP, Marquardt JD. Hematoma block for ankle fractures: a safe and efficacious technique for manipulations. J Orthop Trauma. 1995 Apr;9(2):113-6. doi: 10.1097/00005131-199504000-00004.

Reference Type: BACKGROUND

PMID: 7776029 (View on PubMed)

Singh GK, Manglik RK, Lakhtakia PK, Singh A. Analgesia for the reduction of Colles fracture. A comparison of hematoma block and intravenous sedation. Online J Curr Clin Trials. 1992 Oct 1;Doc No 23:[3614 words; 43 paragraphs].

Reference Type: BACKGROUND

PMID: 1343612 (View on PubMed)

Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev. 1991 Nov;20(11):977-9.

Reference Type: BACKGROUND

PMID: 1749663 (View on PubMed)

Walker KJ, McGrattan K, Aas-Eng K, Smith AF. Ultrasound guidance for peripheral nerve blockade. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD006459. doi: 10.1002/14651858.CD006459.pub2.

Reference Type: BACKGROUND

PMID: 19821368 (View on PubMed)

Atkinson P, Lennon R. Use of emergency department ultrasound in the diagnosis and early management of femoral fractures. Emerg Med J. 2003 Jul;20(4):395. doi: 10.1136/emj.20.4.395. No abstract available.

Reference Type: BACKGROUND

PMID: 12835377 (View on PubMed)

Crystal CS, Miller MA, Young SE. Ultrasound guided hematoma block: a novel use of ultrasound in the traumatized patient. J Trauma. 2007 Feb;62(2):532-3. doi: 10.1097/01.ta.0000244398.89188.9c. No abstract available.

Reference Type: BACKGROUND

PMID: 17297348 (View on PubMed)

Kiely PD, O'Farrell D, Riordan J, Harmon D. The use of ultrasound-guided hematoma blocks in wrist fractures. J Clin Anesth. 2009 Nov;21(7):540-2. doi: 10.1016/j.jclinane.2009.01.008. No abstract available.

Reference Type: BACKGROUND

PMID: 20006267 (View on PubMed)

Other Identifiers

2014P000173

Identifier Type: -

Identifier Source: org_study_id