Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT03195413|
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : October 24, 2018
|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|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- Complications [ Time Frame: 4 weeks ]Complications from the nerve blocks (i.e. compartment syndrome, persistent nerve symptoms) will be measured on follow up.
- 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.
- 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.
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
|United States, Washington|
|Harborview Medical Center / University of Washington|
|Seattle, Washington, United States, 98104|
|Study Director:||Michael Vrablik, DO||University of Washington Emergency Medicine|