IAL vs PS for Anterior Shoulder Dislocations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Glenohumeral Cortisone Injection

NCT04216017

Humeral Fractures

COMPLETED PHASE2

A Prospective Study of the Effect of Treatment of First Time Traumatic Shoulder Anterior Dislocation by Immobilization in External Rotation on the Incidence of Recurrent Dislocation

NCT01648335

Dislocation of the Shoulder

UNKNOWN PHASE2

Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation

NCT04823689

Reduction Emergencies Anterior Shoulder Dislocation

COMPLETED NA

Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery

NCT01355757

Rotator Cuff Injury

COMPLETED EARLY_PHASE1

Immobilization in External Rotation of Acute Shoulder Dislocations

NCT00196560

Anterior Shoulder Dislocation

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Dislocation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intra-articular Lidocaine

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

Group Type EXPERIMENTAL

Intra-articular Lidocaine

Intervention Type DRUG

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

Intravenous etomidate or propofol

Group Type ACTIVE_COMPARATOR

Procedural Sedation with etomidate or propofol

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No