Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer
EPIKARD
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
June 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedMarch 2, 2021
February 1, 2021
2.5 years
March 19, 2019
February 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Cumulative consumption of morphine auto-administered in the control group in the first 48 hours : descriptive analysis
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
48 hours
Troponin's peak characterization in the first 48 hours postoperatively.
48 hours
The Pain characterization: Echelle Numérique Standard; standard digital scale
48 hours
The hospitalization length in the intensive care unit
48 hours
- +9 more secondary outcomes
Study Arms (2)
conventional management of postoperative pain
NO INTERVENTIONPatients 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
EXPERIMENTALIn addition to the conventional management of postoperative pain, patients benefit from perioperative treatment sessions with medical device. Patients are recruiting prospectively.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- Remedee SAcollaborator
- Clinical Investigation Centre for Innovative Technology Networkcollaborator
Study Sites (1)
Grenoble Alpes University Hospital
Grenoble, 38043, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Albaladejo, MD, PhD
Grenoble Alpes University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2019
First Posted
March 26, 2019
Study Start
June 16, 2019
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
March 2, 2021
Record last verified: 2021-02