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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04823689
Other study ID # 2019-01 - EPOLUX
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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