Clinical trial NCT03889288: Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer
Official title: Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Replacement
Keywords: pain treatment
intensive care
cardiology
medical device
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Remedee SA
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2019-03-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Cumulative consumption of morphine auto-administered in the experimental group in the first 48 hours : descriptive analysis
timeFrame: 48 hours
Secondary outcomes:
measure: Cumulative consumption of morphine auto-administered in the control group in the first 48 hours : descriptive analysis
timeFrame: 48 hours
measure: 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
timeFrame: 48 hours
measure: Troponin's peak characterization in the first 48 hours postoperatively.
timeFrame: 48 hours
measure: The Pain characterization: Echelle Numérique Standard; standard digital scale
timeFrame: 48 hours
measure: The hospitalization length in the intensive care unit
timeFrame: 48 hours
measure: Characterization of analgesic drugs
timeFrame: 48 hours
measure: Number of postoperative nausea or vomiting events (number of PONV) in the experimental group
timeFrame: 48 hours
measure: Delirium events in the experimental group
timeFrame: 48 hours
measure: Adverse effect from the medical device
timeFrame: 48 hours
measure: Description of the medical device use
timeFrame: 48 hours
measure: Medical device acceptability : score
timeFrame: 48 hours
measure: Medical device acceptability : descriptive analysis
timeFrame: 48 hours
measure: Use Error evaluation : System Usability Scale (SUS)
timeFrame: 48 hours
measure: Subgroup analysis excluding patients who have had Nefopam administration
timeFrame: 48 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Pierre Albaladejo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: