IAL vs PS for Anterior Shoulder Dislocations

Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations

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

Study Overview

• Status: Unknown
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Drug: Intra-articular Lidocaine; Drug: Procedural Sedation with etomidate or propofol

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33175
      • Recruiting
      • Kendall Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Length of Stay	The elapsed time over which the patient is physically in the emergency department	Anticipated 1-4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Reduction Attempts	The number of attempts it took the physician to reduce the shoulder dislocation	Each attempt takes under 5 minutes
Patient Satisfaction	The patient's satisfaction on a scale from 0-10	The patient is asked their satisfaction just prior to discharge (generally within 4 hours)

Collaborators and Investigators

• Sponsor: Kendall Healthcare Group, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): May 2, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Lidocaine; Etomidate
• Other Study ID Numbers: 2018-233-Non-NSU Health

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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.

Drug and device information, study documents

• 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