search
Back to results

IAL vs PS for Anterior Shoulder Dislocations

Primary Purpose

Shoulder Dislocation

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intra-articular Lidocaine
Procedural Sedation with etomidate or propofol
Sponsored by
Kendall Healthcare Group, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kendall Regional Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intra-articular Lidocaine

Procedural Sedation

Arm Description

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

Intravenous etomidate or propofol

Outcomes

Primary Outcome Measures

Emergency Department Length of Stay
The elapsed time over which the patient is physically in the emergency department

Secondary Outcome Measures

Number of Reduction Attempts
The number of attempts it took the physician to reduce the shoulder dislocation
Patient Satisfaction
The patient's satisfaction on a scale from 0-10

Full Information

First Posted
June 18, 2018
Last Updated
August 12, 2019
Sponsor
Kendall Healthcare Group, Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03625076
Brief Title
IAL vs PS for Anterior Shoulder Dislocations
Official Title
Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
May 2, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kendall Healthcare Group, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-articular Lidocaine
Arm Type
Experimental
Arm Description
20 mL of 1% lidocaine injected into the joint of the dislocated shoulder
Arm Title
Procedural Sedation
Arm Type
Active Comparator
Arm Description
Intravenous etomidate or propofol
Intervention Type
Drug
Intervention Name(s)
Intra-articular Lidocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Procedural Sedation with etomidate or propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emergency Department Length of Stay
Description
The elapsed time over which the patient is physically in the emergency department
Time Frame
Anticipated 1-4 hours
Secondary Outcome Measure Information:
Title
Number of Reduction Attempts
Description
The number of attempts it took the physician to reduce the shoulder dislocation
Time Frame
Each attempt takes under 5 minutes
Title
Patient Satisfaction
Description
The patient's satisfaction on a scale from 0-10
Time Frame
The patient is asked their satisfaction just prior to discharge (generally within 4 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Zitek, MD
Phone
305-480-6602
Email
zitek10@gmail.com
Facility Information:
Facility Name
Kendall Regional Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Zitek, MD
Phone
305-480-6602
Email
zitek10@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
If, after data collection, we feel that the release of IPD will increase the clarity of our data, we might make IPD available to other researchers.

Learn more about this trial

IAL vs PS for Anterior Shoulder Dislocations

We'll reach out to this number within 24 hrs