Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195413
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Arvin Akhavan, University of Washington

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.

Condition or disease Intervention/treatment Phase
Hand Injuries Hand Injuries and Disorders Procedure: Ultrasound-guided forearm nerve block Drug: 1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine Device: Bedside ultrasound machine Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Complications [ Time Frame: 4 weeks ]
    Complications from the nerve blocks (i.e. compartment syndrome, persistent nerve symptoms) will be measured on follow up.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195413


Locations
Layout table for location information
United States, Washington
Harborview Medical Center / University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Layout table for investigator information
Study Director: Michael Vrablik, DO University of Washington Emergency Medicine

Publications:

Layout table for additonal information
Responsible Party: Arvin Akhavan, Resident Physician, University of Washington
ClinicalTrials.gov Identifier: NCT03195413     History of Changes
Other Study ID Numbers: STUDY00001627
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Arvin Akhavan, University of Washington:
Hand blast injury
Nerve block
Hand injury
Forearm nerve block
Ultrasound guided nerve block
Ultrasound nerve block
Emergency department
Emergency physician
Emergency room
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Hand Injuries
Wounds and Injuries
Disease Attributes
Pathologic Processes
Lidocaine
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents