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

Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation : a Prospective Randomized Trial

The anterior glenohumeral dislocation is frequently encountered in emergency medicine. It represents about 50% of the total dislocation and affects 1 resident for 10 000 in France.

In Nord Franche-Comte Hospital, 1 to 2 patients per day present this diagnosis in the emergency department, which requires reduction by external manoeuvres.

A retrospective study shows the interest of the ventral decubitus compared to dorsal decubitus reduction in the care of patients with anterior glenohumeral dislocation. None prospective study has already demonstrate the interest of the ventral decubitus compared to the dorsal decubitus in the reduction of anterior glenohumeral dislocation.

The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.

Study Overview

• Status: Completed
• Conditions: Emergencies; Anterior Shoulder Dislocation; Reduction
• Intervention / Treatment: Procedure: reductions

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Belfort, France
    • Hôpital Nord Franche-Comté

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with radiological confirmed anterior glenohumeral dislocation
• Patient affiliated or entitled to a social security scheme
• Oral informed consent form

Exclusion Criteria:

• Glenohumeral fracture or vasculoneural lesion associated
• Dislocation for more than 12 hours
• Homolateral shoulder surgery antecedent
• Contraindication to other analgesics (morphine, sedation)
• BMI > 40
• Patient < 18 year
• Pregnancy or nursing woment
• Person under guardianship or curatorship

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
Sham Comparator: Dorsal decubitus; The dorsal decubitus reduction consists in placing the patient in the dorsal position and achieving reduction by traction maneuvers on the luxated upper limb. This maneuver generally requires procedural sedation. A mild traction of the traumatized limb in the axis is performed, with slight external rotation and progressive abduction. In the absence of reduction at this stage, this gesture is completed by a flexion adduction of the limb. A counterweight is then made by a rolled sheet and passed under the armpit of the patient.	Procedure: reductions; Two reduction techniques are compared: dorsal decubitus and ventral decubitus reduction. The dorsal decubitus reduction consists in placing the patient in the dorsal position and achieving reduction by traction maneuvers on the luxated upper limb. This maneuver generally requires procedural sedation. A mild traction of the traumatized limb in the axis is performed, with slight external rotation and progressive abduction. In the absence of reduction at this stage, this gesture is completed by a flexion adduction of the limb. A counterweight is then made by a rolled sheet and passed under the armpit of the patient. The ventral decubitus reduction consists in placing the patient in the ventral position. The luxated limb is positioned in pendulum and the line of contact with the stretcher must pass through the mid-clavicular line. The humeral head is brought to the scapula.
Experimental: Ventral decubitus; The ventral decubitus reduction consists in placing the patient in the ventral position. The luxated limb is positioned in pendulum and the line of contact with the stretcher must pass through the mid-clavicular line. The humeral head is brought to the scapula.	Procedure: reductions; Two reduction techniques are compared: dorsal decubitus and ventral decubitus reduction. The dorsal decubitus reduction consists in placing the patient in the dorsal position and achieving reduction by traction maneuvers on the luxated upper limb. This maneuver generally requires procedural sedation. A mild traction of the traumatized limb in the axis is performed, with slight external rotation and progressive abduction. In the absence of reduction at this stage, this gesture is completed by a flexion adduction of the limb. A counterweight is then made by a rolled sheet and passed under the armpit of the patient. The ventral decubitus reduction consists in placing the patient in the ventral position. The luxated limb is positioned in pendulum and the line of contact with the stretcher must pass through the mid-clavicular line. The humeral head is brought to the scapula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.	The primary endpoint is the reduction time in minutes from inclusion of the patient after prior confirmation of the clinical and radiological diagnosis to the observed reduction.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique	Failure rate of the ventral decubitus technique compared to the dorsal decubitus technique	1 day
Evaluation of the consumption of sedative and analgesic treatments	Quantification of doses of analgesics and sedatives used	1 day
Evaluation of the time spent in emergency department	Time spent in emergency department	1 day
Evaluation of the pain felt before and after the intervention	Pain sensibility before, during et after the reduction techniques : visual analog pain scale	1 day

Collaborators and Investigators

• Sponsor: Hopital Nord Franche-Comte

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): February 10, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Disease Attributes; Joint Diseases; Skin Diseases; Skin Ulcer; Emergencies; Joint Dislocations; Shoulder Dislocation; Pressure Ulcer
• Other Study ID Numbers: 2019-01 - EPOLUX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No