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

Emergencies Clinical Trial

— EPOLUX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823689
• Other study ID #: 2019-01 - EPOLUX
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2023
• Source: Hopital Nord Franche-Comte
• Contact: Elodie Bouvier
• Phone: 0384983570
• Email: elodie.bouvier[@]hnfc.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2024
• Est. primary completion date: July 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Shoulder Dislocation
• Emergencies
• Pressure Ulcer
• Reduction
• Shoulder Dislocation

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Nord Franche-Comté	Belfort

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Nord Franche-Comte

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evaluation of the consumption of sedative and analgesic treatments	Quantification of doses of analgesics and sedatives used	1 day
Secondary	Evaluation of the time spent in emergency department	Time spent in emergency department	1 day
Secondary	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