Recruiting

IAL vs. PS

Sponsor:

Kendall Healthcare Group, Ltd.

Code:

NCT03625076

Conditions

Shoulder Dislocation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Intra-articular Lidocaine

Procedural Sedation with etomidate or propofol

Study Details

Brief summary:

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

Conditions

Shoulder Dislocation

Study ID

NCT03625076

Start date

Jun 1, 2018

Status verified date

Aug, 2019

Completion date

Jun 1, 2020

Anticipated

Primary completion date

May 2, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not 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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intra-articular Lidocaine

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

active comparator: Procedural Sedation

Intravenous etomidate or propofol

Interventions

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.

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.

Primary outcome measure

  • Emergency Department Length of Stay [ Time Frame: Anticipated 1-4 hours ]

Central Contacts and Locations

Central contacts

Tony Zitek, MD

305-480-6602zitek10@gmail.com

Locations

Kendall Regional Medical Center

Recruiting

Miami, Florida, United States, 33175

Contacts

Tony Zitek, MD

305-480-6602zitek10@gmail.com

More Information

Sponsor

Kendall Healthcare Group, Ltd.

Last update posted

Aug 13, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kendall Healthcare Group, Ltd. on 2019-08-13.