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Clinical Trials/NCT04823689
NCT04823689CompletedNot Applicable

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

Hopital Nord Franche-Comte1 site in 1 country120 target enrollmentStarted: July 21, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: reductions (Procedure)

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.

Intervention: reductions (Procedure)

Outcomes

Primary Outcomes

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

  • Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique(1 day)
  • Evaluation of the time spent in emergency department(1 day)
  • Evaluation of the consumption of sedative and analgesic treatments(1 day)
  • Evaluation of the pain felt before and after the intervention(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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