Comparing Virtual Reality Sedation to Neuroleptanalgesia in Outpatient Surgery for Superficial Venous Insufficiency

What this Trial Is About

Researchers are evaluating the use of virtual reality as a method to reduce pain during the endovenous thermal treatment of superficial varicose veins. The study aims to see if virtual reality sedation can delay the need for neuroleptanalgesia when combined with local anesthesia by tumescence. This is a prospective, randomized, open-label study involving 200 patients, focused on comparing pain intensity during surgery. Participants are divided into two groups one group receives local anesthesia by tumescence plus the usual neuroleptanalgesia treatment, while the other group receives local anesthesia with virtual reality software for sedation. The study tests if virtual reality sedation is not inferior to traditional neuroleptanalgesia by measuring maximum intraoperative pain. The entire participation lasts up to 2 days. During the study, pain is assessed immediately after surgery using a numerical rating scale. Researchers will also evaluate pre- and post-operative anxiety, overall patient satisfaction, surgery duration, ICU and hospital stay length, and time to resume normal activities. Safety and treatment details are monitored throughout, with the primary outcome focused on pain intensity on the first day.

Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation