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

Not Applicable

• Conditions: Aortic Valve Replacement
• Interventions: Device: Medical device - electronic-pain killer

• Registration Number: NCT03889288
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-06-16
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-02
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical device - electronic-pain killer	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The hospitalization length in the intensive care unit	48 hours	For the two groups, the hospitalization length in the intensive care unit is assessed in hours.
Characterization of analgesic drugs	48 hours	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.
Number of postoperative nausea or vomiting events (number of PONV) in the experimental group	48 hours	In the experimental group, the number of PONV events requiring a treatment is assessed.
Delirium events in the experimental group	48 hours	The number of delirium events is assessed using the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) scale in the experimental group.
Cumulative consumption of morphine auto-administered in the control group in the first 48 hours : descriptive analysis	48 hours	The morphine cumulative consumption administered by auto-analgesia in the control group at 24 and 48 hours after the surgery
Troponin's peak characterization in the first 48 hours postoperatively.	48 hours	The troponin is assessed in ng/ml in the two groups from the end of the surgery until 48 hours postoperatively
Medical device acceptability : score	48 hours	This score has been specifically created for the electronic pain killer medical device. Each item range from 0 (the worst) to 10 (the best).
Medical device acceptability : descriptive analysis	48 hours	Open questions will be asked in a questionnaire without scale. A descriptive analysis will be done with the answers.
Adverse effect from the medical device	48 hours	The number of adverse effects from the medical device is assessed from the first session with the medical device to the follow-up visit.
Description of the medical device use	48 hours	Log files of the medical device are extracted. The length of each session, the start and end session times, each stopping is analysed.
Use Error evaluation : System Usability Scale (SUS)	48 hours	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).
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	Cumulative morphine consumption in milligrams, administered by auto-analgesia, at 48 hours post-operatively in the experimental and control groups.
The Pain characterization: Echelle Numérique Standard; standard digital scale	48 hours	The patient pain is evaluated using the ENS (Echelle Numérique Standard; standard digital scale, score between 0 to 10) for both groups.
Subgroup analysis excluding patients who have had Nefopam administration	48 hours	To avoid a potential bias confusion, patients taking Nefopam drug are excluded from the analyses and all the previous outcome are assessed again.

Trial Locations

Locations (1)

Grenoble Alpes University Hospital; 🇫🇷 Grenoble, France