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

Anterior Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821517
• Other study ID #: 21-AOI-11
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: HAMARD Fanny
• Phone: 04 92 03 85 81
• Email: hamard.f[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Shoulder Dislocation
• Shoulder Dislocation

Intervention

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

Drug:
• Administration of METHOXYFLURANE
Self administered inhalated methoxyflurane (maximal inhaled dose : 3 mL)
• 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.

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The amount of co-antalgesics administered	Posology of co-analgesic medications administered	3 months
Secondary	The duration of the procedure	Time lenght of the reduction procedure	Day 1 (day of change of anterior shoulder dislocation)
Secondary	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)
Secondary	The average length of stay in the emergency department	Average length of stay in the emergency department	3 months
Secondary	Patient satisfaction	Patient satisfaction at the end of care evaluated with a questionnaire EVA	3 months
Secondary	The rate of reduction-related complications	Complications related to the reduction	3 months