NCT03195413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

June 17, 2017

Last Update Submit

October 22, 2018

Conditions

Keywords

Hand blast injuryNerve blockHand injuryForearm nerve blockUltrasound guided nerve blockUltrasound nerve blockEmergency departmentEmergency physicianEmergency room

Outcome Measures

Primary Outcomes (1)

  • Pain Score (1-100 visual or verbal scale)

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

    3 hour

Secondary Outcomes (3)

  • Complications

    4 weeks

  • Opioid medication use

    1 day

  • Additional pain scores (1-100 visual or verbal scale)

    0 - 3 hours

Study Arms (2)

Nerve Block Arm

EXPERIMENTAL

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 blockDrug: 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrineDevice: Bedside ultrasound machine

Control Arm

NO INTERVENTION

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.

Interventions

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.

Also known as: Nerve block
Nerve Block Arm

This is the anesthetic solution that will be administered during the ultrasound-guided nerve block

Nerve Block Arm

This is the device that will be used to visualize tissues during the ultrasound-guided nerve block.

Nerve Block Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center / University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (10)

  • 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.

    PMID: 11561245BACKGROUND
  • 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.

    PMID: 20978218BACKGROUND
  • 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.

    PMID: 14570678BACKGROUND
  • 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.

    PMID: 15277302BACKGROUND
  • 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.

    PMID: 4983335BACKGROUND
  • 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.

    PMID: 17499669BACKGROUND
  • 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.

    PMID: 27461885BACKGROUND
  • 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.

    PMID: 25803747BACKGROUND
  • 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.

    PMID: 17052557BACKGROUND
  • 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.

    PMID: 26931789BACKGROUND

MeSH Terms

Conditions

Hand InjuriesDiseaseEmergencies

Interventions

Nerve BlockLidocaineEpinephrineBupivacaine

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Michael Vrablik, DO

    University of Washington Emergency Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

June 17, 2017

First Posted

June 22, 2017

Study Start

July 1, 2017

Primary Completion

July 10, 2018

Study Completion

July 10, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations