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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-16

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Replacement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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conventional management of postoperative pain

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Medical device - electronic-pain killer

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

Group Type EXPERIMENTAL

Medical device - electronic-pain killer

Intervention Type DEVICE

Treatment sessions with the medical device (no-marked EC): 2 sessions before surgery and 4 or 5 sessions until 48 hours after surgery. Each treatment sessions takes 45 minutes. Each session is spaced by 12 +/-3 hours.

Interventions

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Medical device - electronic-pain killer

Treatment sessions with the medical device (no-marked EC): 2 sessions before surgery and 4 or 5 sessions until 48 hours after surgery. Each treatment sessions takes 45 minutes. Each session is spaced by 12 +/-3 hours.

Intervention Type DEVICE

Eligibility Criteria

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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)

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No