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METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)

Primary Purpose

Anterior Shoulder Dislocation

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Helmet virtual reality.
Administration of METHOXYFLURANE
Standard of care
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Shoulder Dislocation

Eligibility Criteria

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

Inclusion Criteria: Pregnant and/or breastfeeding women and women of childbearing age who do not have effective contraception (hormonal, mechanical or surgical). Patients with difficulties in understanding or using the devices studied. Patients with a contraindication to the use of one of the studied devices. Patients with a history of relevant shoulder surgery Presence of other associated trauma, Previous inclusion in the same study Exclusion Criteria: Withdrawal of voluntary informed consent from the patient Violation of protocol Presence of a fracture associated with the dislocation (excluding Malgaigne's notches) Posterior, inferior or erecta dislocation Presence of initial vascular and nerve complications Any indication for surgical management

Sites / Locations

  • Nice University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard of care

Medical device : VR headset

Medication : Methoxyflurane analgesia

Arm Description

An anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure.

Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care

Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)

Outcomes

Primary Outcome Measures

Decrease in the rate of procedural sedation of anterior shoulder dislocation
Rate of use of procedural sedation for anterior shoulder dislocation reduction in the interventional groups compared to the control group

Secondary Outcome Measures

The amount of co-antalgesics administered
Posology of co-analgesic medications administered
The duration of the procedure
Time lenght of the reduction procedure
The dosage of drugs used in procedural sedation
Posology of sedative drugs administered for a procedural sedation
The average length of stay in the emergency department
Average length of stay in the emergency department
Patient satisfaction
Patient satisfaction at the end of care evaluated with a questionnaire EVA
The rate of reduction-related complications
Complications related to the reduction

Full Information

First Posted
March 10, 2023
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05821517
Brief Title
METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)
Official Title
METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

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
Anterior shoulder dislocation is a pathology frequently encountered in emergency medicine. The success in reducing anterior shoulder dislocations depends on muscle relaxation, which is itself conditioned by the patient's pain and apprehension. However, there is no consensus on the optimal technique for reducing anterior shoulder dislocation or the analgesia associated with it. Analgesia with METHOXYFLURANE showed a greater reduction in post-traumatic pain compared to standard analgesic treatment and faster action of METHOXYFLURANE. A retrospective study which has compared analgesia with METHOXYFLURANE and analgesic sedation with PROPOFOL found a shoulder reduction success rate of 80% and a reduction in the average length of stay in the emergency department. Finally, the use of virtual reality in pain management is emerging in our practices by allowing pre- and per-procedure hypno-sedation-analgesia. However, the use of virtual reality headsets has not been studied in the management of anterior shoulder dislocation. The use of these two techniques could therefore limit the use of procedural sedation in the context of shoulder dislocation reduction.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
An anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure.
Arm Title
Medical device : VR headset
Arm Type
Experimental
Arm Description
Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care
Arm Title
Medication : Methoxyflurane analgesia
Arm Type
Experimental
Arm Description
Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)
Intervention Type
Device
Intervention Name(s)
Helmet virtual reality.
Intervention Description
Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care
Intervention Type
Drug
Intervention Name(s)
Administration of METHOXYFLURANE
Intervention Description
Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
An anticipated analgesia protocol composed of PARACETAMOL 1g +/- OXYNORM 5 mg or 10 mg according to patients weight and pain intensity as evaluated by a simple numeric rating scale is administred prior to the reduction procedure. Inhaled equimolar mixture of oxygen and notrous oxyde (MEOPA) at a 15L/min flux is administered concomitantly to the reduction procedure.
Primary Outcome Measure Information:
Title
Decrease in the rate of procedural sedation of anterior shoulder dislocation
Description
Rate of use of procedural sedation for anterior shoulder dislocation reduction in the interventional groups compared to the control group
Time Frame
Day 1 (day of reduction of anterior shoulder dislocation)
Secondary Outcome Measure Information:
Title
The amount of co-antalgesics administered
Description
Posology of co-analgesic medications administered
Time Frame
3 months
Title
The duration of the procedure
Description
Time lenght of the reduction procedure
Time Frame
Day 1 (day of change of anterior shoulder dislocation)
Title
The dosage of drugs used in procedural sedation
Description
Posology of sedative drugs administered for a procedural sedation
Time Frame
Day 1 (day of reduction of anterior shoulder dislocation)
Title
The average length of stay in the emergency department
Description
Average length of stay in the emergency department
Time Frame
3 months
Title
Patient satisfaction
Description
Patient satisfaction at the end of care evaluated with a questionnaire EVA
Time Frame
3 months
Title
The rate of reduction-related complications
Description
Complications related to the reduction
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant and/or breastfeeding women and women of childbearing age who do not have effective contraception (hormonal, mechanical or surgical). Patients with difficulties in understanding or using the devices studied. Patients with a contraindication to the use of one of the studied devices. Patients with a history of relevant shoulder surgery Presence of other associated trauma, Previous inclusion in the same study Exclusion Criteria: Withdrawal of voluntary informed consent from the patient Violation of protocol Presence of a fracture associated with the dislocation (excluding Malgaigne's notches) Posterior, inferior or erecta dislocation Presence of initial vascular and nerve complications Any indication for surgical management
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HAMARD Fanny
Phone
04 92 03 85 81
Email
hamard.f@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
RAPP Jocelyn
Phone
04 92 03 85 35
Email
rapp.j@chu-nice.fr
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanny Hamard
Phone
0492038581
Email
hamard.f@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
laurent Bouchama
Phone
0492038581
Email
bouchama.l@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Fanny Hamard
First Name & Middle Initial & Last Name & Degree
laurent Bouchama

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation (HYPNOLUX)

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