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

October 22, 2018 updated by: Arvin Akhavan, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center / University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerve Block Arm
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.
Procedure: Ultrasound-guided forearm nerve block
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.
Other Names:
  • Nerve block
Drug: 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine
This is the anesthetic solution that will be administered during the ultrasound-guided nerve block
Device: Bedside ultrasound machine
This is the device that will be used to visualize tissues during the ultrasound-guided nerve block.
No Intervention: Control Arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score (1-100 visual or verbal scale)
Time Frame: 3 hour
Pain score (1-100 visual or verbal scale) at 3 hours post-block
3 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 4 weeks
Complications from the nerve blocks (i.e. compartment syndrome, persistent nerve symptoms) will be measured on follow up.
4 weeks
Opioid medication use
Time Frame: 1 day
The amount (in morphine equivalents) number of doses of opioid medications used in the emergency department will be measured.
1 day
Additional pain scores (1-100 visual or verbal scale)
Time Frame: 0 - 3 hours
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.
0 - 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Study Director: Michael Vrablik, DO, University of Washington Emergency Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

July 10, 2018

Study Registration Dates

First Submitted

June 17, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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