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Systemic Absorption of Lidocaine After Hematoma Block

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359017
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

This study will measure in children how much numbing medicine, lidocaine, is absorbed into the bloodstream after it is injected into a blood clot (hematoma) around a forearm fracture for pain control when the broken bone is moved back into place (fracture reduction). This is called a hematoma block and is commonly used in the Emergency Unit. To help with anxiety and to add additional pain control, nitrous oxide (laughing gas) is given while the lidocaine hematoma block is placed and continued during the fracture reduction. Advantages of using this technique for pain control instead of an intravenous anesthetic such as ketamine include faster recovery and discharge home, and longer pain control.

Of concern, if too much lidocaine is absorbed into the bloodstream, seizures and irregular heart beating may occur. Bloodstream concentrations of lidocaine after a hematoma block have been measured in only one study of 8 adults and found to be at significant but safe levels. No study has been published in children to measure bloodstream lidocaine levels when a hematoma block is used. Because children's bones are still growing and more metabolically active than adult bones, the investigators believe it is important to determine whether lidocaine blood levels in children are also at safe levels when using a standard lidocaine hematoma block for reduction of fractures. The investigators also want to determine whether bloodstream lidocaine levels correlate with type of fracture, size of the fracture hematoma and effectiveness of pain control during fracture reduction.

The investigators also aim to determine if there is a difference in absorption pattern between different types of distal radius fractures, if there is a correlation between fracture type and systemic lidocaine absorption, if there this a correlation between fracture type and fracture hematoma size, and if there is a correlation between fracture type and ability to provide adequate pain and sedation control with lidocaine hematoma block/inhaled nitrous combination. The investigators believe blood lidocaine levels after hematoma block in children will peak at safe levels, but will be higher than those observed in adults. They believe that a more displaced fracture will have a larger hematoma, that a larger hematoma will be associated with a higher peak blood lidocaine level, and that a higher peak blood lidocaine level will be associated with more successful pain control scores and satisfaction with the procedure.


Condition or disease Intervention/treatment Phase
Radius Fracture Distal Hematoma Lidocaine Pediatrics Drug: Lidocaine 1% Injectable Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systemic Absorption of Lidocaine After Hematoma Block for Reduction of Different Types of Pediatric Distal Radius Fractures
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lidocaine Hematoma Block Drug: Lidocaine 1% Injectable Solution
The lidocaine will be injected into the fracture hematoma using buffered 1% lidocaine solution at a dose of 2.5 mg/kg (0.25 mL/kg), maximum dose 100 mg (10 mL). Using a 30-gauge needle to minimize pain, a small skin wheal of lidocaine will be injected over the fracture site. A 21-gauge needle will then be attached to the lidocaine filled syringe and passed through the skin wheal used to inject the lidocaine into the fracture hematoma. To confirm the needle is in the fracture hematoma, a small amount of blood from the hematoma will be aspirated into the syringe filled with lidocaine before injecting the lidocaine, as in standard practice.




Primary Outcome Measures :
  1. Plasma Lidocaine Levels [ Time Frame: Serial plasma lidocaine levels will be measured during a single subject's distal forearm fracture reduction, to be measured over the course of 60 minutes form the injection of lidocaine into the hematoma block. ]
    Measured concentrations of plasma lidocaine levels for subjects undergoing lidocaine hematoma block for their distal radius fracture reduction.


Secondary Outcome Measures :
  1. Pediatric Sedation State Scale Scores [ Time Frame: This will be assessed every 60 seconds throughout the process of reduction and splinting of the subject's fracture. The scale ranges from a score of 0 to 5, with 0-1 and 4-5 being undesirable, 2-3 being desirable (appropriately sedated). ]
    Measurement of patient overall comfort (in terms of sedation) will be assessed by an observer using the Pediatric Sedation State Scale scoring system during the reduction of the subjects fracture.


Other Outcome Measures:
  1. Satisfaction scores [ Time Frame: This will be obtained immediately after procedure is complete, and will be a Likert scale from 0-10 where 0 is not satisfied at all and 10 is very satisfied. ]
    Satisfaction with the procedure and level of provided analgesia and sedation will be assessed from the parent, subject, sedationist and orthopedist.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA status class 1 or 2
  • Ages 5-17
  • Parent/guardian is present

Exclusion Criteria:

  • Open fracture
  • Previous attempt at reduction
  • Multiple other injuries
  • Physeal (growth plate) fractures
  • Volar displacement of the distal fracture fragment
  • Delayed presentation (>48 hrs from injury)
  • Concern for significant neurovascular injury
  • Refracture through a healing fracture
  • History of adverse effect from lidocaine or nitrous oxide
  • Active psychosis
  • Non English speaking parents
  • Liver disease
  • Cardiac disease
  • Abnormal bones such as osteogenesis imperfecta or osteopenia from lack of use
  • Developmental abnormalities

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): NCT04359017


Contacts
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Contact: Allie Grither, MD 3144542341 grither_a@wustl.edu
Contact: Robert Kennedy, MD 3144542341 kennedy@wustl.edu

Locations
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United States, Missouri
Saint Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Allie Grither         
Sponsors and Collaborators
Washington University School of Medicine
Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04359017    
Other Study ID Numbers: 202004180
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hematoma
Radius Fractures
Fractures, Bone
Wounds and Injuries
Forearm Injuries
Arm Injuries
Hemorrhage
Pathologic Processes
Lidocaine
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