IAL vs PS for Anterior Shoulder Dislocations

Shoulder Dislocation Clinical Trial

Official title:

Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03625076
• Other study ID #: 2018-233-Non-NSU Health
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: August 2019
• Source: Kendall Healthcare Group, Ltd.
• Contact: Tony Zitek, MD
• Phone: 305-480-6602
• Email: zitek10[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2020
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Drug:
• Intra-articular Lidocaine
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.
• Procedural Sedation with etomidate or propofol
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.

Locations

Country	Name	City	State
United States	Kendall Regional Medical Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kendall Healthcare Group, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergency Department Length of Stay	The elapsed time over which the patient is physically in the emergency department	Anticipated 1-4 hours
Secondary	Number of Reduction Attempts	The number of attempts it took the physician to reduce the shoulder dislocation	Each attempt takes under 5 minutes
Secondary	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)