search
Back to results

Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department

Primary Purpose

Hand Injuries, Hand Injuries and Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-guided forearm nerve block
1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine
Bedside ultrasound machine
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries focused on measuring Hand blast injury, Nerve block, Hand injury, Forearm nerve block, Ultrasound guided nerve block, Ultrasound nerve block, Emergency department, Emergency physician, Emergency room

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient with moderate to severe hand blast injury or other significantly painful hand or distal forearm injury Also, patients who...
  • Are awake and alert
  • Are able to endorse or rate their pain
  • Require intravenous pain medication for their hand injury
  • Are determined to be clinically sober for consent. They will need to be fluent of speech and able to articulate understanding of the procedure they will undergo and the study they will enter.

Exclusion Criteria:

Patient's who...

  • Require surgical management, within one half hour, for any injury
  • Require any emergent care, including resuscitation, the should preclude their regional pain management
  • Are hemodynamically unstable
  • Have signs of coagulopathy
  • Have clinical features suggestive of compartment syndrome of the forearm, including:

    • Tense or firm forearm compartment
    • Expanding hematoma
    • Regional neurologic deficit (weakness or numbness)
  • Have weakness or a sensory deficit in an intact part of their hand or forearm
  • Have a vascular injury proximal to the hand
  • Are unconscious or otherwise unable to endorse or rate their pain
  • Are not deemed clinically sober enough to articulate an understanding of the procedure they will undergo and the study they will enter.
  • Are prisoners
  • Are <18 years old

Sites / Locations

  • Harborview Medical Center / University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nerve Block Arm

Control Arm

Arm Description

This group of patients will receive an ultrasound-guided forearm block intervention by the study team. The nerve block will be achieved with a solution of 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine (mixed in a 1:1 volume ratio) dosed once. A second dose will be given only in the case of complete block failure.

This group will receive the standard of care in our emergency department, as determined by their primary team. If a patient here receives a nerve block from the primary team, they will be handled with intention-to-treat analysis.

Outcomes

Primary Outcome Measures

Pain Score (1-100 visual or verbal scale)
Pain score (1-100 visual or verbal scale) at 3 hours post-block

Secondary Outcome Measures

Complications
Complications from the nerve blocks (i.e. compartment syndrome, persistent nerve symptoms) will be measured on follow up.
Opioid medication use
The amount (in morphine equivalents) number of doses of opioid medications used in the emergency department will be measured.
Additional pain scores (1-100 visual or verbal scale)
Pain scores (1-100 visual or verbal scale) at time of block, 15 minutes after block, and one hour after block, and 2 hours after block.

Full Information

First Posted
June 17, 2017
Last Updated
October 22, 2018
Sponsor
University of Washington
search

1. Study Identification

Unique Protocol Identification Number
NCT03195413
Brief Title
Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department
Official Title
Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to determine whether early initiation of temporary nerve block therapy improves patient satisfaction, decreases patient pain and discomfort, decreases the use of dangerous medications such as narcotics, and frees hospital resources. Hand injuries, such as blast injuries from fireworks, can be very painful. In the emergency department, providers generally use narcotic pain medications to control pain, but these have significant side effects. It is possible that temporary nerve blocks, guided by ultrasound, can be safe and useful in the emergency department. They have been shown to be effective in several studies around the country. The goal of this study is to build on the experience of others to increase the use of US-guided regional nerve blocks as a form of pain management in hand and distal forearm injuries in the Harborview Medical Center (HMC) emergency department. By working with a multidisciplinary team, the study investigators hope to use this technique to decrease narcotic use and improve pain control, and to provide important data for Emergency Medicine physicians elsewhere who are considering incorporating this nerve block technique into their practice.
Detailed Description
Hand and forearm pain secondary to fracture, laceration, dislocation, infection, and blast injury is a common issue in the emergency department (ED). Pain control is particularly important in these patients as they frequently require manipulation of their injured extremity for suturing, reduction, splinting, or abscess drainage. Pain management has traditionally centered on the use of parenteral narcotics. These medications can have significant side effects, especially in the elderly and those with comorbid diseases, and may not provide sufficient pain control in these cases, specifically in those with opioid tolerance or gruesome blast injuries. Regional nerve blocks have proven a useful tool in the management of extremity pain but have been traditionally limited to use by anesthesiologists in order to limit side effects such as intravascular infiltration and nerve damage. However, the use of direct visualization with ultrasound (US) can minimize these risks and emergency medicine (EM) physicians are using nerve blocks with increasing frequency. Recent emergency medicine literature has been promising with regard to the successful use of US-guided regional nerve blocks for finger reduction, upper extremity fractures, dislocations, abscess drainage, and hand blast injuries in the emergency department. In one case series, nerve blocks were used successfully in pediatric patients and studies measuring feasibility have found that these blocks can be done in less than ten minutes, and without significant complications. However, more studies are needed before these blocks become standard of care in all institutions. Studies that evaluate the use of other pain medications in the setting of these blocks would be particularly helpful. Academic institutions are using US-guided nerve blocks with increasing frequency. In a recent publication 121 academic instructions provided information on usage of this technique. 84% of programs perform US-guided nerve blocks, most commonly forearm nerve blocks (ulnar, median, or radial nerves). Nerve block technique is taught via didactic sessions, online resources, and supervised training. However, most of the programs do not have specific agreements with other specialty services with regard to performing US-guided nerve blocks in the ED. One group has successfully created a multidisciplinary approach to treat blast injuries to the hand which includes EM physicians and surgeons. This team recognized the importance of surgical evaluation prior to nerve block in blast injuries to assess for risk of compartment syndrome. No cases of compartment syndrome were reported in this case series and pain control provided by the nerve block allowed the surgical team to evaluate the extent of injuries, irrigate the wound thoroughly, and employ temporizing measures such as sutures and splints while the patient waited for definitive management. However, this aforementioned study was inherently limited in that it was a feasibility study. While promising, further work that establishes forearm blocks by ED physicians in the setting of severe hand injuries as safe and effective can guide us as to whether this mode of pain management should be standard of care. A major goal of this study will be to provide important data for emergency physicians when they consider whether or not to include these blocks into their practice. To that end, the study investigators present a randomized controlled trial where patients with blast injuries will be randomized to standard-of-care versus early ultrasound-guided nerve block as an intervention. Measured outcomes will include pain scores, complications, and opioid use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries, Hand Injuries and Disorders
Keywords
Hand blast injury, Nerve block, Hand injury, Forearm nerve block, Ultrasound guided nerve block, Ultrasound nerve block, Emergency department, Emergency physician, Emergency room

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nerve Block Arm
Arm Type
Experimental
Arm Description
This group of patients will receive an ultrasound-guided forearm block intervention by the study team. The nerve block will be achieved with a solution of 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine (mixed in a 1:1 volume ratio) dosed once. A second dose will be given only in the case of complete block failure.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
This group will receive the standard of care in our emergency department, as determined by their primary team. If a patient here receives a nerve block from the primary team, they will be handled with intention-to-treat analysis.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided forearm nerve block
Other Intervention Name(s)
Nerve block
Intervention Description
An ultrasound machine will be used to identify the median, radial, and ulnar nerves in the forearm, so that a needle may be used to apply lidocaine into the soft tissue space around those nerves.
Intervention Type
Drug
Intervention Name(s)
1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine
Intervention Description
This is the anesthetic solution that will be administered during the ultrasound-guided nerve block
Intervention Type
Device
Intervention Name(s)
Bedside ultrasound machine
Intervention Description
This is the device that will be used to visualize tissues during the ultrasound-guided nerve block.
Primary Outcome Measure Information:
Title
Pain Score (1-100 visual or verbal scale)
Description
Pain score (1-100 visual or verbal scale) at 3 hours post-block
Time Frame
3 hour
Secondary Outcome Measure Information:
Title
Complications
Description
Complications from the nerve blocks (i.e. compartment syndrome, persistent nerve symptoms) will be measured on follow up.
Time Frame
4 weeks
Title
Opioid medication use
Description
The amount (in morphine equivalents) number of doses of opioid medications used in the emergency department will be measured.
Time Frame
1 day
Title
Additional pain scores (1-100 visual or verbal scale)
Description
Pain scores (1-100 visual or verbal scale) at time of block, 15 minutes after block, and one hour after block, and 2 hours after block.
Time Frame
0 - 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient with moderate to severe hand blast injury or other significantly painful hand or distal forearm injury Also, patients who... Are awake and alert Are able to endorse or rate their pain Require intravenous pain medication for their hand injury Are determined to be clinically sober for consent. They will need to be fluent of speech and able to articulate understanding of the procedure they will undergo and the study they will enter. Exclusion Criteria: Patient's who... Require surgical management, within one half hour, for any injury Require any emergent care, including resuscitation, the should preclude their regional pain management Are hemodynamically unstable Have signs of coagulopathy Have clinical features suggestive of compartment syndrome of the forearm, including: Tense or firm forearm compartment Expanding hematoma Regional neurologic deficit (weakness or numbness) Have weakness or a sensory deficit in an intact part of their hand or forearm Have a vascular injury proximal to the hand Are unconscious or otherwise unable to endorse or rate their pain Are not deemed clinically sober enough to articulate an understanding of the procedure they will undergo and the study they will enter. Are prisoners Are <18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Vrablik, DO
Organizational Affiliation
University of Washington Emergency Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Harborview Medical Center / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11561245
Citation
Chung KC, Spilson SV. The frequency and epidemiology of hand and forearm fractures in the United States. J Hand Surg Am. 2001 Sep;26(5):908-15. doi: 10.1053/jhsu.2001.26322.
Results Reference
background
PubMed Identifier
20978218
Citation
Patanwala AE, Keim SM, Erstad BL. Intravenous opioids for severe acute pain in the emergency department. Ann Pharmacother. 2010 Nov;44(11):1800-9. doi: 10.1345/aph.1P438. Epub 2010 Oct 26.
Results Reference
background
PubMed Identifier
14570678
Citation
Williams SR, Chouinard P, Arcand G, Harris P, Ruel M, Boudreault D, Girard F. Ultrasound guidance speeds execution and improves the quality of supraclavicular block. Anesth Analg. 2003 Nov;97(5):1518-1523. doi: 10.1213/01.ANE.0000086730.09173.CA.
Results Reference
background
PubMed Identifier
15277302
Citation
Marhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J Anaesth. 2005 Jan;94(1):7-17. doi: 10.1093/bja/aei002. Epub 2004 Jul 26.
Results Reference
background
PubMed Identifier
4983335
Citation
Witwicki T, Dziak A. [Sarcomatous degeneration in the course of Recklinghausen's neurofibromatosis]. Chir Narzadow Ruchu Ortop Pol. 1969;34(6):809-11. No abstract available. Polish.
Results Reference
background
PubMed Identifier
17499669
Citation
Stone MB, Price DD, Wang R. Ultrasound-guided supraclavicular block for the treatment of upper extremity fractures, dislocations, and abscesses in the ED. Am J Emerg Med. 2007 May;25(4):472-5. doi: 10.1016/j.ajem.2006.08.019.
Results Reference
background
PubMed Identifier
27461885
Citation
Wroe P, O'Shea R, Johnson B, Hoffman R, Nagdev A. Ultrasound-guided forearm nerve blocks for hand blast injuries: case series and multidisciplinary protocol. Am J Emerg Med. 2016 Sep;34(9):1895-7. doi: 10.1016/j.ajem.2016.06.111. Epub 2016 Jul 11. No abstract available.
Results Reference
background
PubMed Identifier
25803747
Citation
Frenkel O, Liebmann O, Fischer JW. Ultrasound-guided forearm nerve blocks in kids: a novel method for pain control in the treatment of hand-injured pediatric patients in the emergency department. Pediatr Emerg Care. 2015 Apr;31(4):255-9. doi: 10.1097/PEC.0000000000000398.
Results Reference
background
PubMed Identifier
17052557
Citation
Liebmann O, Price D, Mills C, Gardner R, Wang R, Wilson S, Gray A. Feasibility of forearm ultrasonography-guided nerve blocks of the radial, ulnar, and median nerves for hand procedures in the emergency department. Ann Emerg Med. 2006 Nov;48(5):558-62. doi: 10.1016/j.annemergmed.2006.04.014. Epub 2006 Jun 14.
Results Reference
background
PubMed Identifier
26931789
Citation
Amini R, Kartchner JZ, Nagdev A, Adhikari S. Ultrasound-Guided Nerve Blocks in Emergency Medicine Practice. J Ultrasound Med. 2016 Apr;35(4):731-6. doi: 10.7863/ultra.15.05095. Epub 2016 Mar 1.
Results Reference
background

Learn more about this trial

Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department

We'll reach out to this number within 24 hrs