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

Aortic Valve Replacement Clinical Trial

— EPIKARD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03889288
• Other study ID #: 38RC18.170
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: January 2022

Study information

• Verified date: February 2021
• Source: University Hospital, Grenoble
• Contact: Pierre Albaladejo, MD, PhD
• Phone: +33 4 76 76 92 88
• Email: palbaladejo[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Replacement

Intervention

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.

Locations

Country	Name	City	State
France	Grenoble Alpes University Hospital	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology, Remedee Labs SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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