Clinical trial NCT02346929: Hematoma Block for Distal Radius Fracture
Official title: Comparison of Ultrasound-guided Hematoma Block and "Blind" Hematoma Block for Analgesia in Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Hematoma block
distal radius fracture reduction
ultrasound
ultrasound guided hematoma block
traditional hematoma block for analgesia
bupivacaine
pain reduction
wrist fracture
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2015-01-27
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Reduction as indicated by Visual Analog Scale
timeFrame: 4 hours after initiation of study procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Beatrice Hoffmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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].
citation: Johnson PQ, Noffsinger MA. Hematoma block of distal forearm fractures. Is it safe? Orthop Rev. 1991 Nov;20(11):977-9.
citation: 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.
citation: 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.
citation: 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.
citation: 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.