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

Primary Purpose

Reduction, Emergencies, Anterior Shoulder Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
reductions
Sponsored by
Hopital Nord Franche-Comte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Nord Franche-ComtéRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Dorsal decubitus

Ventral decubitus

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Evaluation of the consumption of sedative and analgesic treatments
Quantification of doses of analgesics and sedatives used
Evaluation of the time spent in emergency department
Time spent in emergency department
Evaluation of the pain felt before and after the intervention
Pain sensibility before, during et after the reduction techniques : visual analog pain scale

Full Information

First Posted
March 26, 2021
Last Updated
October 10, 2023
Sponsor
Hopital Nord Franche-Comte
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1. Study Identification

Unique Protocol Identification Number
NCT04823689
Brief Title
Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation
Acronym
EPOLUX
Official Title
Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation : a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
July 21, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Nord Franche-Comte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction, Emergencies, Anterior Shoulder Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dorsal decubitus
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Ventral decubitus
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
reductions
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
Evaluation of the success rate of the ventral decubitus technique compared to the dorsal decubitus technique
Description
Failure rate of the ventral decubitus technique compared to the dorsal decubitus technique
Time Frame
1 day
Title
Evaluation of the consumption of sedative and analgesic treatments
Description
Quantification of doses of analgesics and sedatives used
Time Frame
1 day
Title
Evaluation of the time spent in emergency department
Description
Time spent in emergency department
Time Frame
1 day
Title
Evaluation of the pain felt before and after the intervention
Description
Pain sensibility before, during et after the reduction techniques : visual analog pain scale
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Bouvier
Phone
0384983570
Email
elodie.bouvier@hnfc.fr
Facility Information:
Facility Name
Hôpital Nord Franche-Comté
City
Belfort
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie Bouvier
Email
elodie.bouvier@hnfc.fr

12. IPD Sharing Statement

Learn more about this trial

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

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