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NCT Number: NCT05821517

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

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.

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Key information

Conditions

Anterior Shoulder Dislocation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Helmet virtual reality.

Device

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

Administration of METHOXYFLURANE

Drug

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

Standard of care

Drug

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 outcomes

  1. Decrease in the rate of procedural sedation of anterior shoulder dislocation

    Time frame: 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 outcomes

  1. The amount of co-antalgesics administered

    Time frame: 3 months

    Posology of co-analgesic medications administered

  2. The duration of the procedure

    Time frame: Day 1 (day of change of anterior shoulder dislocation)

    Time lenght of the reduction procedure

  3. The dosage of drugs used in procedural sedation

    Time frame: Day 1 (day of reduction of anterior shoulder dislocation)

    Posology of sedative drugs administered for a procedural sedation

  4. The average length of stay in the emergency department

    Time frame: 3 months

    Average length of stay in the emergency department

  5. Patient satisfaction

    Time frame: 3 months

    Patient satisfaction at the end of care evaluated with a questionnaire EVA

  6. The rate of reduction-related complications

    Time frame: 3 months

    Complications related to the reduction

Study contacts

Contact information is provided by the study sponsor or research team.

HAMARD Fanny

CONTACT

[email protected]

04 92 03 85 81

RAPP Jocelyn

CONTACT

[email protected]

04 92 03 85 35

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 20, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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