Informations générales (source: ClinicalTrials.gov)
Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group (EPIKARD)
Interventional
N/A
University Hospital, Grenoble (Voir sur ClinicalTrials)
juin 2019
janvier 2022
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Grenoble Alpes University Hospital - 38043 - Grenoble - France | Pierre Albaladejo, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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