Evaluation of the Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery - A Single-Center, Randomized, Controlled Proof-of-Concept Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group
Study Overview
Brief Summary
Acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year. Effective analgesic therapy in the first postoperative week is a key factor in reducing early postoperative morbidity and mortality. Poorly controlled APOP is a major risk factor for chronic postoperative pain. In France today, more and more patients undergo surgical procedures as outpatients. The challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either after outpatient surgery or after a prompt return home as part of an Enhanced Recovery After Surgery (ERAS) protocol. In outpatient surgery, postoperative pain management requires new strategies and/or organizational approaches to ensure high-quality pain management from the very start. The principle of analgesia for acute postoperative pain recommends: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy if maintenance therapy is insufficient, based on pain titration, using mild or strong oral opioids. Postoperative pain is the primary focus of postoperative care but the goal is also to improve postoperative recovery and enhance the patient's overall care. To date, there are no medical telemonitoring devices to support the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, enabling systematic postoperative screening for early and late warning signs of the risk of chronic pain. The Thess Monitoring device, which implements the ANTALGEEK® protocol, (TMA) was developed to optimize the efficiency of outpatient management of acute postoperative pain. It improves patients' adherence to maintenance treatment with adaptive, personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing). The aim is to ensure optimal pain resolution and improve early and late postoperative recovery during the first postoperative week. The TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain. By measuring pain scores daily during the first postoperative week, it identifies patients with a suboptimal pain trajectory who are at high risk of developing persistent pain beyond the third month. It also assesses warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3). Improving the patient care pathway via the TMA system should make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.
Detailed Description
The problem of acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year and potentially leading to numerous complications when inadequately managed. In the postoperative period, the implementation of effective analgesic therapy is a key factor in reducing early postoperative morbidity and mortality. Furthermore, poorly controlled PPS is one of the major risk factors for the development of chronic postoperative pain (CPOP). Optimizing analgesic medication to prevent an abnormal pain trajectory during the first postoperative week is a key strategy for preventing chronic postoperative pain.
Today, within the French healthcare system, an increasing number of patients undergo surgical procedures performed on an outpatient basis. The big challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either following outpatient surgery or after an early return home as part of an Enhanced Recovery After Surgery (ERAS) protocol.
In outpatient surgery, improving postoperative pain management requires the implementation of new strategies and/or organizational approaches to ensure a high-quality pain management pathway from the very beginning.
The principle of analgesia for acute postoperative pain recommends a combination of: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy-if maintenance therapy is insufficient-based on the principle of pain titration, using oral opioids (mild or strong). While postoperative pain remains the primary focus of postoperative care, the goal is also to improve postoperative recovery more broadly and thereby enhance the patient's overall care.
The assessment of postoperative recovery in outpatient surgery patients using a medical telemonitoring device is associated with a reduction in discomfort caused by various postoperative symptoms, including postoperative pain. However, to date, there is no medical telemonitoring device that both supports the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, and enables systematic postoperative screening for early and late warning signs of the risk of chronic pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
None (open-label).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients eligible for outpatient surgery.
- •Patients undergoing surgery likely to result in moderate to severe pain.
- •Patients available for a 3-month follow-up.
- •Patients who have provided their free and informed consent.
- •Patients who have signed the consent form.
- •Patients enrolled in or covered by a health insurance plan.
Exclusion Criteria
- •Patients participating in an interventional RIPH study involving a drug or classified as Category
- •Patients in an exclusion period determined by another study.
- •Patients under judicial protection, guardianship, or conservatorship.
- •Patients unable to express consent.
- •Patient for whom it is impossible to provide informed information.
- •Pregnant, laboring, or breastfeeding patients.
Arms & Interventions
Postoperative pain management : standard care
Patients receiving standard postoperative analgesic care
Postoperative pain management using the Thess telemonitoring device
Patients being monitored with the Thess Monitoring medical telemonitoring device in conjunction with the ANTALGEEK® protocol
Intervention: Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol (Device)
Outcomes
Primary Outcomes
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group
Time Frame: Day 2
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score \> 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the standard care (control) group.
Time Frame: Day 2
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score \> 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
Secondary Outcomes
- Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group(Day 1, before the intervention)
- Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group(Day 1, after the intervention)
- Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group(Day 7)
- Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group(Day 1, before the intervention)
- Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group(Day 1, after the intervention)
- Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group(Day 7)
- Pain progression in the experimental group(Day 1)
- Pain progression in the experimental group(Day 2)
- Pain progression in the experimental group(Day 3)
- Pain progression in the experimental group(Day 4)
- Pain progression in the experimental group(Day 5)
- Pain progression in the experimental group(Day 6)
- Pain progression in the experimental group(Day 7)
- Pain progression in the experimental group(Month 1)
- Pain progression in the experimental group(Month 2)
- Pain progression in the experimental group(Month 3)
- Pain progression in the in the standard care (control) group(Day 1)
- Pain progression in the in the standard care (control) group(Day 2)
- Pain progression in the in the standard care (control) group(Day 3)
- Pain progression in the in the standard care (control) group(Day 4)
- Pain progression in the in the standard care (control) group(Day 5)
- Pain progression in the in the standard care (control) group(Day 6)
- Pain progression in the in the standard care (control) group(Day 7)
- Pain progression in the in the standard care (control) group(Month 1)
- Pain progression in the in the standard care (control) group(Month 2)
- Pain progression in the in the standard care (control) group(Month 3)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 0)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 0)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 1)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the in the standard care (control) group(Day 1)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 2)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 2)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 3)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 3)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 4)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 4)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 5)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 5)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 6)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 6)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 7)
- Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 7)
- Incidence of adverse effects associated with opioid use in the experimental group(Day 0)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Day 0)
- Incidence of adverse effects associated with opioid use in the experimental group(Day 1)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Day 1)
- Incidence of adverse effects associated with opioid use in the experimental group(Day 2)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Day 2)
- Incidence of adverse effects associated with opioid use in the experimental group(Day 3)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Day 3)
- Incidence of adverse effects associated with opioid use in the experimental group(Day 4)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Day 4)
- Incidence of adverse effects associated with opioid use in the experimental group(Day 5)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Day 5)
- Incidence of adverse effects associated with opioid use in the experimental group(Day 6)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Day 6)
- Incidence of adverse effects associated with opioid use in the experimental group(Day 7)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Day 7)
- Safety in the experimental group(Day 7)
- Safety in the standard care (control) group(Day 7)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Day 1)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Day 1)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Day 2)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Day 2)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Day 3)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Day 3)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Day 4)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Day 4)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Day 5)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Day 5)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Day 6)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Day 6)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Day 7)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Day 7)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Month 1)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Month 1)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group(Month 3)
- Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group(Month 3)
- Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group(Day 1)
- Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group(Day 1)
- Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group(Day 2)
- Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group(Day 2)
- Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group(Day 3)
- Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group(Day 3)
- Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group(Day 4)
- Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group(Day 4)
- Prescription issued outside of those prescribed upon hospital discharge in the experimental group(Month 3)
- Prescription issued outside of those prescribed upon hospital discharge in the standard care(control) group(Month 3)
- Number of days of sick leave prescribed in the experimental group(Month 3)
- Number of days of sick leave prescribed in the standard care (control) group(Month 3)
- Satisfaction questionnaire administered to the patient in the experimental group(Day 3)
- Satisfaction questionnaire administered to the patient in the standard care (control) group(Day 3)
- Satisfaction questionnaire administered to the anesthesiologist in the experimental group(End of the inclusion period)
- Satisfaction questionnaire administered to the anesthesiologist in the standard care (control) group(End of the inclusion period)
- System Usability Scale score during the follow-up call to patients in the experimental group(Day 30)
- System Usability Scale score from health providers to the experimental group(End of the inclusion period)
- Collection of incidents, malfunctions, and organization deviations that occurred during implementation in the experimental group(Month 3)
- System Usability Scale score during the follow-up call to patients in the standard care (control) group(Day 30)
- System Usability Scale score from health providers to the standard care (control) group(End of the inclusion period)
- DN2 questionnaire score in the experimental group(Post-operative Month 1)
- DN2 questionnaire score in the experimental group(Post-operative Month 2)
- DN2 questionnaire score in the experimental group(Post-operative Month 3)
- DN2 questionnaire score in the standard care (control) group(Post-operative Month 1)
- DN2 questionnaire score in the standard care (control) group(Post-operative Month 2)
- DN2 questionnaire score in the standard care (control) group(Post-operative Month 3)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 2)
- Time spent connected to the Thess Monitoring device per patient in the experimental group(Month 3)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Baseline)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Baseline)
- rate of adherence to the standard pain management regimen (non-opioid analgesics) in the in the standard care (control) group(Day 1)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 2)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 3)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 3)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 4)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 4)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 5)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 5)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 6)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 6)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group(Day 7)
- Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group(Day 7)
- Incidence of adverse effects associated with opioid use in the experimental group(Baseline)
- Incidence of adverse effects associated with opioid use in the standard care (control) group(Baseline)
- Adverse Events [Safety and Tolerability] in the experimental group(Day 7)
- Adverse Events [Safety and Tolerability]in the standard care (control) group(Day 7)
- Rate of incidents, malfunctions, and organization deviations that occurred during implementation in the experimental group(Month 3)