IAL vs PS for Anterior Shoulder Dislocations
Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations
1 other identifier
interventional
70
1 country
1
Brief Summary
This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 18, 2018
CompletedFirst Posted
Study publicly available on registry
August 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 13, 2019
August 1, 2019
1.9 years
June 18, 2018
August 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Emergency Department Length of Stay
The elapsed time over which the patient is physically in the emergency department
Anticipated 1-4 hours
Secondary Outcomes (2)
Number of Reduction Attempts
Each attempt takes under 5 minutes
Patient Satisfaction
The patient is asked their satisfaction just prior to discharge (generally within 4 hours)
Study Arms (2)
Intra-articular Lidocaine
EXPERIMENTAL20 mL of 1% lidocaine injected into the joint of the dislocated shoulder
Procedural Sedation
ACTIVE COMPARATORIntravenous etomidate or propofol
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Patients 18-70 years old in the emergency department with an anterior shoulder dislocation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kendall Regional Medical Center
Miami, Florida, 33175, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2018
First Posted
August 10, 2018
Study Start
June 1, 2018
Primary Completion
May 2, 2020
Study Completion
June 1, 2020
Last Updated
August 13, 2019
Record last verified: 2019-08