Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer

Last updated: February 25, 2021
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03889288
38RC18.170
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. This new modality of pain management is evaluated in a perioperative management in patients undergoing surgery for aortic valve replacement.

The hypothesis is that the use of this medical device in perioperative would reduce the consumption of postoperative morphine with an identical quality of analgesia. The decline in morphine consumption would allow a decrease in opioid adverse effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • candidate for an aortic valve replacement with extra-corporal flow.

  • wrist size between 14.5 and 18.5 centimeters (for the experimental group)

  • patient affiliated to social security

  • signature of the informed consent (for the experimental group)

Exclusion Criteria for the control group :

  • patient with diabetes

  • patient with an evolutive cancer

  • patient with cardiac assistance

  • patient under the influence of opioid in the 48 hours before the surgery

  • patient deprived of liberty by judicial or administrative decision

  • patient subject to legal protection or unable to express his consent (guardianship or curators)

Exclusion Criteria for the experimental group :

  • patient with diabetes

  • patient with an evolutive cancer

  • patient with surgery planning within 48 hours

  • patient with cardiac assistance

  • patient under the influence of opioid in the 48 hours before the surgery

  • patient suffering from a dermatological disease such as oozing dermatitis, hyper sweating, or an unhealed lesion in the wrists.

  • patient who has a piercing in the wrist or another metal material

  • patient known for having a multi-resistant bacterial strain

  • protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

  • exclusion period of another interventional study

Study Design

Total Participants: 110
Study Start date:
June 16, 2019
Estimated Completion Date:
January 31, 2022

Connect with a study center

  • Grenoble Alpes University Hospital

    Grenoble, 38043
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.