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

  • STATUS
    Recruiting
  • End date
    Jan 7, 2022
  • participants needed
    110
  • sponsor
    University Hospital, Grenoble
Updated on 7 March 2021

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.

Details
Condition Aortic Valve Replacement
Treatment Medical device - electronic-pain killer
Clinical Study IdentifierNCT03889288
SponsorUniversity Hospital, Grenoble
Last Modified on7 March 2021

Eligibility

Yes No Not Sure

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

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
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