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Completed

NCT Number: NCT04823689

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

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.

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Key information

Conditions

Reduction Anterior Shoulder Dislocation Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Nord Franche-Comté

Belfort, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 1 day

    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.

Secondary outcomes

  1. Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique

    Time frame: 1 day

    Failure rate of the ventral decubitus technique compared to the dorsal decubitus technique

  2. Evaluation of the consumption of sedative and analgesic treatments

    Time frame: 1 day

    Quantification of doses of analgesics and sedatives used

  3. Evaluation of the time spent in emergency department

    Time frame: 1 day

    Time spent in emergency department

  4. Evaluation of the pain felt before and after the intervention

    Time frame: 1 day

    Pain sensibility before, during et after the reduction techniques : visual analog pain scale

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Official study title

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

Acronym: EPOLUX

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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