IAL vs PS for Anterior Shoulder Dislocations

Sponsor

Kendall Healthcare Group, Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03625076

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Shoulder Dislocation	Drug: Intra-articular Lidocaine Drug: Procedural Sedation with etomidate or propofol	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

May 2, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intra-articular Lidocaine 20 mL of 1% lidocaine injected into the joint of the dislocated shoulder	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.
Active Comparator: Procedural Sedation Intravenous etomidate or propofol	Drug: 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.

Arm

Intervention/Treatment

Experimental: Intra-articular Lidocaine

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

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.

Active Comparator: Procedural Sedation

Intravenous etomidate or propofol

Drug: 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kendall Regional Medical Center	Miami	Florida	United States	33175

Sponsors and Collaborators

Kendall Healthcare Group, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kendall Healthcare Group, Ltd.

ClinicalTrials.gov Identifier:

NCT03625076

Other Study ID Numbers:

2018-233-Non-NSU Health

First Posted:

Aug 10, 2018

Last Update Posted:

Aug 13, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2019