IAL vs PS for Anterior Shoulder Dislocations

Phase 4

• Conditions: Shoulder Dislocation
• Interventions: Drug: Intra-articular Lidocaine; Drug: Procedural Sedation with etomidate or propofol

• Registration Number: NCT03625076
• Lead Sponsor: Kendall Healthcare Group, Ltd.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13
• Primary Completion: 2020-05-02
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-articular Lidocaine	Intra-articular Lidocaine	20 mL of 1% lidocaine injected into the joint of the dislocated shoulder
Procedural Sedation	Procedural Sedation with etomidate or propofol	Intravenous etomidate or propofol

Primary Outcome Measures

Name	Time	Method
Emergency Department Length of Stay	Anticipated 1-4 hours	The elapsed time over which the patient is physically in the emergency department

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kendall Regional Medical Center; 🇺🇸 Miami, Florida, United States