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

Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Replacement
• Intervention / Treatment: Device: Medical device - electronic-pain killer

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Albaladejo, MD, PhD; Phone Number: +33 4 76 76 92 88; Email: palbaladejo@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • Grenoble Alpes University Hospital
    • Contact: Pierre Albaladejo, MD, PhD
    • Sub-Investigator: Caroline Maindet, MD
    • Sub-Investigator: Delphine Rhem, MD
    • Sub-Investigator: Damien Bedague, MD
    • Sub-Investigator: Baptiste Deletombe, MD
    • Sub-Investigator: Géraldine Dessertaine, MD
    • Sub-Investigator: Michel Durand, MD
    • Sub-Investigator: Emmanuelle Fournel, MD
    • Sub-Investigator: Lucie Gaide-Chevronnay, MD
    • Sub-Investigator: Amélie Hebrard, MD
    • Sub-Investigator: Maria Rosaria Marino, MD
    • Sub-Investigator: Pierre-Henri Moury, MD
    • Sub-Investigator: Daniel Protar, MD
    • Sub-Investigator: Sylvaine Robin, MD
    • Sub-Investigator: Romain Zunarelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
EXPERIMENTAL: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative consumption of morphine auto-administered in the experimental group in the first 48 hours : descriptive analysis	The morphine cumulative consumption administered by auto-analgesia in the experimental group at 24 and 48 hours after the surgery	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative consumption of morphine auto-administered in the control group in the first 48 hours : descriptive analysis	The morphine cumulative consumption administered by auto-analgesia in the control group at 24 and 48 hours after the surgery	48 hours
Determine the number of patients required to demonstrate a 30% decrease in morphine consumption within the first 48h following aortic valve replacement surgery in a population treated with "Electronic-Pain-Killer" compared to conventional pain management	Cumulative morphine consumption in milligrams, administered by auto-analgesia, at 48 hours post-operatively in the experimental and control groups.	48 hours
Troponin's peak characterization in the first 48 hours postoperatively.	The troponin is assessed in ng/ml in the two groups from the end of the surgery until 48 hours postoperatively	48 hours
The Pain characterization: Echelle Numérique Standard; standard digital scale	The patient pain is evaluated using the ENS (Echelle Numérique Standard; standard digital scale, score between 0 to 10) for both groups.	48 hours
The hospitalization length in the intensive care unit	For the two groups, the hospitalization length in the intensive care unit is assessed in hours.	48 hours
Characterization of analgesic drugs	The analgesic drugs are characterized by their class, dose and number of dose taken in the two groups since they are in the intensive care unit.	48 hours
Number of postoperative nausea or vomiting events (number of PONV) in the experimental group	In the experimental group, the number of PONV events requiring a treatment is assessed.	48 hours
Delirium events in the experimental group	The number of delirium events is assessed using the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) scale in the experimental group.	48 hours
Adverse effect from the medical device	The number of adverse effects from the medical device is assessed from the first session with the medical device to the follow-up visit.	48 hours
Description of the medical device use	Log files of the medical device are extracted. The length of each session, the start and end session times, each stopping is analysed.	48 hours
Medical device acceptability : score	This score has been specifically created for the electronic pain killer medical device. Each item range from 0 (the worst) to 10 (the best).	48 hours
Medical device acceptability : descriptive analysis	Open questions will be asked in a questionnaire without scale. A descriptive analysis will be done with the answers.	48 hours
Use Error evaluation : System Usability Scale (SUS)	The System Usability Scale (SUS) contains 10 questions that are rated on a scale from 1 to 5. "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100." Jeff Sauro established the average score of SUS is 68. The score can go from 0 (worst) to 100 (best).	48 hours
Subgroup analysis excluding patients who have had Nefopam administration	To avoid a potential bias confusion, patients taking Nefopam drug are excluded from the analyses and all the previous outcome are assessed again.	48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Remedee SA; Clinical Investigation Centre for Innovative Technology Network
• Investigators: Principal Investigator: Pierre Albaladejo, MD, PhD, Grenoble Alpes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 16, 2019
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: medical device; intensive care; cardiology; pain treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 38RC18.170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No