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

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Aortic Valve Replacement

Treatments: Device: Medical device - electronic-pain killer

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT03889288

38RC18.170

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

conventional management of postoperative pain

No Intervention group

Description:

Patients who have had an aortic valve replacement surgery have a conventional management of pain after surgery. The pain is treated by morphine using a patient-controlled analgesia for the administration. Patients are recruiting prospectively or possibly retrospectively. The management is usual, nothing from the conventional care of patients change, only data will be collected.

Medical device - electronic-pain killer

Experimental group

Description:

In addition to the conventional management of postoperative pain, patients benefit from perioperative treatment sessions with medical device. Patients are recruiting prospectively.

Treatment:

Device: Medical device - electronic-pain killer