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

Phase 4

Recruiting

• Conditions: Anterior Shoulder Dislocation
• Interventions: Device: Helmet virtual reality.; Drug: Standard of care; Drug: Administration of METHOXYFLURANE

• Registration Number: NCT05821517
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-20
• Study Start: 2023-05-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-11-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical device : VR headset	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
Standard of care	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.
Medication : Methoxyflurane analgesia	Administration of METHOXYFLURANE	Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)

Primary Outcome Measures

Name	Time	Method
Decrease in the rate of procedural sedation of anterior shoulder dislocation	Day 1 (day of reduction 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

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

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France