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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03195413
Other study ID # STUDY00001627
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date July 10, 2018

Study information

Verified date October 2018
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 10, 2018
Est. primary completion date July 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States Harborview Medical Center / University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. Epub 2006 Jun 14. — View Citation

Marhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J Anaesth. 2005 Jan;94(1):7-17. Epub 2004 Jul 26. Review. — View 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. Review. — View 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. — View 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):1518-23. — View Citation

Witwicki T, Dziak A. [Sarcomatous degeneration in the course of Recklinghausen's neurofibromatosis]. Chir Narzadow Ruchu Ortop Pol. 1969;34(6):809-11. Polish. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Score (1-100 visual or verbal scale) Pain score (1-100 visual or verbal scale) at 3 hours post-block 3 hour
Secondary Complications Complications from the nerve blocks (i.e. compartment syndrome, persistent nerve symptoms) will be measured on follow up. 4 weeks
Secondary Opioid medication use The amount (in morphine equivalents) number of doses of opioid medications used in the emergency department will be measured. 1 day
Secondary 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. 0 - 3 hours
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