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IAL vs PS for Anterior Shoulder Dislocations

Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03625076
Enrollment
70
Registered
2018-08-10
Start date
2018-06-01
Completion date
2020-06-01
Last updated
2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

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.

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.

DRUGProcedural 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.

Sponsors

Kendall Healthcare Group, Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Emergency Department Length of StayAnticipated 1-4 hoursThe elapsed time over which the patient is physically in the emergency department

Secondary

MeasureTime frameDescription
Patient SatisfactionThe patient is asked their satisfaction just prior to discharge (generally within 4 hours)The patient's satisfaction on a scale from 0-10
Number of Reduction AttemptsEach attempt takes under 5 minutesThe number of attempts it took the physician to reduce the shoulder dislocation

Countries

United States

Contacts

Primary ContactTony Zitek, MD
zitek10@gmail.com305-480-6602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026