IAL vs PS for Anterior Shoulder Dislocations

Kendall Healthcare

Status and phase: Unknown; Phase 4

Conditions: Shoulder Dislocation

Treatments: Drug: Procedural Sedation with etomidate or propofol; Drug: Intra-articular Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03625076

2018-233-Non-NSU Health

Details and patient eligibility

About

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

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Intra-articular Lidocaine

Experimental group

Description:

20 mL of 1% lidocaine injected into the joint of the dislocated shoulder

Treatment:

Drug: Intra-articular Lidocaine

Procedural Sedation

Active Comparator group

Description:

Intravenous etomidate or propofol

Treatment:

Drug: Procedural Sedation with etomidate or propofol