Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction

Study Overview
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Brief Summary
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The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.

Official Title
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Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?

Conditions
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Forearm Fracture

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English or Spanish speaking Ages 3-17 Closed distal forearm fracture requiring reduction under sedation in the Emergency Department Fracture involves the distal third of the forearm Exclusion Criteria: Multiple trauma victims Associated nerve or vascular damage Associated elbow or humerus injury Sensitivity or allergy to lidocaine Contraindications to procedural sedation Previous attempts at reduction for the same injury

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block. | Drug: Lidocaine<br>* 2% Lidocaine (no epinephrine) in the dose of 2.5 mg/kg to a maximum of 10mL will be instilled once into the fracture site in the form of a hematoma block.<br>* Other names: Lidocaine hydrochloride;|
| Placebo Comparator: Normal Saline<br>Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site | Drug: Saline<br>* Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.<br>* Other names: Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sedation time |  | Evaluated upon completion of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-union |  | 1 month | 
| Need for re-manipulation |  | 1 week | 
| Adverse effects of sedation |  | For the duration of the procedure | 
| Adverse effects of hematoma block |  | 1 month | 
| Pain control |  | For entire duration of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematoma block, Lidocaine, Forearm fracture, Radius fracture, Ulna fracture, Ketamine, Midazolam, Procedural sedation