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

NCT04823689 | Completed

• 1 other identifier: 2019-01 - EPOLUX
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reduction; Emergencies; Anterior Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique

  1 day

• Evaluation of the consumption of sedative and analgesic treatments

  1 day

• Evaluation of the time spent in emergency department

  1 day

• Evaluation of the pain felt before and after the intervention

  1 day

Study Arms (2)

Dorsal decubitus

SHAM COMPARATOR

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

Ventral decubitus

EXPERIMENTAL

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

Interventions

reductions PROCEDURE

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.

Dorsal decubitus; Ventral decubitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Nord Franche-Comte: lead

Study Sites (1)

Hôpital Nord Franche-Comté

Belfort, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: July 21, 2021
• Primary Completion: February 10, 2024
• Study Completion: June 25, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)