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Systemic Absorption of Lidocaine After Hematoma Block

NCT04359017 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-12-18

No results posted yet for this study

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.

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, 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.

Conditions

  • Radius Fracture Distal
  • Hematoma
  • Lidocaine
  • Pediatrics

Interventions

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359017 on ClinicalTrials.gov