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CompletedNCT04823689EPOLUXUpdated Dec 27, 2024

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

An interventional study of reductions in Reduction, Emergencies and Anterior Shoulder Dislocation, sponsored by Hopital Nord Franche-Comte. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Hopital Nord Franche-Comte · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Reduction
  • Emergencies
  • Anterior Shoulder Dislocation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Sham comparator
    Dorsal decubitus

    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

  • Experimental
    Ventral decubitus

    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

  • Procedurereductions

    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.

05

What researchers measure

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.

    Time frame: 1 day

Secondary outcomes

  1. 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

    Time frame: 1 day

  2. Evaluation of the consumption of sedative and analgesic treatments

    Quantification of doses of analgesics and sedatives used

    Time frame: 1 day

  3. Evaluation of the time spent in emergency department

    Time spent in emergency department

    Time frame: 1 day

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

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

    Time frame: 1 day

06

Study locations

1 site
  • Hôpital Nord Franche-Comté
    Belfort, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04823689
Lead sponsor
Hopital Nord Franche-Comte
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Jul 21, 2021
Primary completion
Feb 10, 2024
Completion
Jun 25, 2024
Last update
Dec 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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