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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Shoulder Dislocation
• Intervention / Treatment: Drug: Standard of care; Device: Helmet virtual reality.; Drug: Administration of METHOXYFLURANE

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: HAMARD Fanny; Phone Number: 04 92 03 85 81; Email: hamard.f@chu-nice.fr
• Study Contact Backup: Name: RAPP Jocelyn; Phone Number: 04 92 03 85 35; Email: rapp.j@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Nice University Hospital
    • Contact: laurent Bouchama; Phone Number: 0492038581; Email: bouchama.l@chu-nice.fr
    • Contact: Fanny Hamard; Phone Number: 0492038581; Email: hamard.f@chu-nice.fr
    • Principal Investigator: Fanny Hamard
    • Sub-Investigator: laurent Bouchama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; 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.	Drug: Standard of care; 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.
Experimental: Medical device : VR headset; Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care	Device: Helmet virtual reality.; Use of a " virtual reality " (VR) headset of " Pico G2 " type with " HypnoVR " software and audio headset " Taotronics BH22 " during all the reduction care
Experimental: Medication : Methoxyflurane analgesia; Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)	Drug: Administration of METHOXYFLURANE; Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 (day of reduction of anterior shoulder dislocation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of co-antalgesics administered	Posology of co-analgesic medications administered	3 months
The dosage of drugs used in procedural sedation	Posology of sedative drugs administered for a procedural sedation	Day 1 (day of reduction of anterior shoulder dislocation)
The average length of stay in the emergency department	Average length of stay in the emergency department	3 months
The rate of reduction-related complications	Complications related to the reduction	3 months
The duration of the procedure	Time lenght of the reduction procedure	Day 1 (day of change of anterior shoulder dislocation)
Patient satisfaction	Patient satisfaction at the end of care evaluated with a questionnaire EVA	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 21-AOI-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No