IAL vs PS for Anterior Shoulder Dislocations

Study Overview
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Brief Summary
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This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.

Detailed Description
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This will be a single center, prospective, open-label, randomized controlled trial on a convenience sample of patients presenting to the ED with anterior shoulder dislocations. This study will enroll all patients between the ages of 18 and 70 who meet all of the inclusion criteria and do not meet any of the exclusion criteria, who present to the ED with an anterior shoulder dislocation as determined by the ED physician. Written, informed consent will be obtained from each patient. After enrollment, each patient will be randomized either to IV sedation (with the provider's choice of propofol or etomidate) or intra-articular lidocaine. Randomization will be done before the initiation of data collection, and will be done with a random number generator. Patients who are randomized to the intra-articular group will receive 20 mL of 1% lidocaine injected into the glenohumeral joint using a lateral approach. Treating clinicians will be instructed to wait 10 minutes after injection before attempting reduction. The primary outcome measure will be the difference in emergency department length of stay between the procedural sedation and intra-articular lidocaine groups.

Official Title
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Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Drug: Intra-articular Lidocaine
* Drug: Procedural Sedation with etomidate or propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18-70 years old in the emergency department with an anterior shoulder dislocation. Exclusion Criteria: Pregnant or breastfeeding Is a prisoner. Known allergy to one of the study drugs. Altered mental status. Shoulder fracture (other than a Hill-Sachs) associated with the dislocation. Attending provider excludes patient.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-articular Lidocaine<br>20 mL of 1% lidocaine injected into the joint of the dislocated shoulder | Drug: Intra-articular Lidocaine<br>* 20 mL of 1% Lidocaine will be injected into the joint of the dislocated shoulder. Afterwards, the physician will attempt to reduce the shoulder using a technique of his or her choice.<br>|
| Active Comparator: Procedural Sedation<br>Intravenous etomidate or propofol | Drug: Procedural Sedation with etomidate or propofol<br>* Procedural sedation using etomidate or propofol (physician's choice) will be performed. The dose of the drugs will also be left the treating physician. The physician will then attempt to reduce the shoulder using a technique of his or her choice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Department Length of Stay | The elapsed time over which the patient is physically in the emergency department | Anticipated 1-4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Reduction Attempts | The number of attempts it took the physician to reduce the shoulder dislocation | Each attempt takes under 5 minutes | 
| Patient Satisfaction | The patient's satisfaction on a scale from 0-10 | The patient is asked their satisfaction just prior to discharge (generally within 4 hours) |