Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block. (VRBLOC)

Clinique Saint Jean, France

Status: Completed

Conditions: Hallux Valgus; Surgery

Treatments: Drug: Sufentanyl; Drug: Droleptan; Device: Virtual reality; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03677323

LOCAL2017-TP02

Details and patient eligibility

About

The purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.

Full description

Currently, in preparation for forefoot surgery, the realization of the ankle block is accompanied by drug sedation.

The investigator's randomized study aims to compare the anxiety and pain experienced by patients who have benefited from drug sedation with those of patients who benefited from the virtual reality device at the time of the realization of the ankle block.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with medical insurance
• Major patient requiring a Hallux Valgus surgery
• Patient who received information about study and signes a consent to participate in the study

Exclusion criteria

• Minor patient
• Patient participating in another interventional study
• Patient refusing to sign the consent form
• Patient for whom it is impossible to give informed information
• Patient who had previously undergone forefoot surgery under locoregional anesthesia
• Patient with poor skin condition or infection at puncture sites
• Patient refusing locoregional anesthesia
• Patient under the protection of justice, under curatorship or under tutorship
• Patient undergoing anxiolytic or antidepressant treatment
• Photosensitive epileptic patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Virtual reality

Experimental group

Description:

The virtual reality device will consist of the virtual reality headset and headphones for full immersion.

Treatment:

Device: Virtual reality

Drug sedation

Active Comparator group

Description:

The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.

Treatment:

Drug: Propofol

Drug: Droleptan

Drug: Sufentanyl