Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery

Официальное название

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.

Обзор

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.

Подробное описание

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.

To this end, the Thess Monitoring medical telemonitoring device (which implements the ANTALGEEK® protocol) (TMA) was developed. It is a tool for continuous therapeutic support and postoperative telemonitoring designed to optimize the efficiency of outpatient management of acute postoperative pain in patients by improving adherence to maintenance therapy, adaptive and 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), with the goal of ensuring optimal pain resolution and improved early and late postoperative recovery during the first postoperative week (Baseline-Day 7). To achieve this, 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: identify, through daily measurement of pain scores during the first postoperative week, patients with a suboptimal pain trajectory who are at high risk of developing persistent postoperative pain beyond the third month; assess 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 through the TMA system should thus make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.

In this initial proof-of-concept study, the investigators aim to evaluate the performance and safety of the TMA medical device in the outpatient management of acute pain during the first postoperative week, as well as its impact on postoperative recovery and on reducing the risk of pain becoming chronic by the third postoperative month.

Вмешательства

• Устройство Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol
  The Thess monitoring medical device (Thess Corp., Montpellier) uses the remote ANTALGEEK® telemonitoring protocol to manage pain in outpatients who have had surgery causing moderate-to-severe pain. It digitalizes and optimizes acute postoperative pain management at home by improving adherence to maintenance therapy, with adaptive, tailored control of analgesia through better use of opioid rescue therapy to reduce the adverse effects of opioid misuse and ensures optimal pain resolution and postop

Первичные конечные точки

• Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group [Срок оценки: Day 2]
• Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the standard care (control) group. [Срок оценки: Day 2]

Вторичные конечные точки (12)

• Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group [Срок оценки: Day 1, before the intervention]
• Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group [Срок оценки: Day 1, after the intervention]
• Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group [Срок оценки: Day 7]
• Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group [Срок оценки: Day 1, before the intervention]
• Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group [Срок оценки: Day 1, after the intervention]
• Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group [Срок оценки: Day 7]
• Pain progression in the experimental group [Срок оценки: Day 1]
• Pain progression in the experimental group [Срок оценки: Day 2]
• Pain progression in the experimental group [Срок оценки: Day 3]
• Pain progression in the experimental group [Срок оценки: Day 4]
• Pain progression in the experimental group [Срок оценки: Day 5]
• Pain progression in the experimental group [Срок оценки: Day 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Patients participating in an interventional RIPH study involving a drug or classified as Category 1.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Nimes University Hospital — Nîmes

Публикации

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Идентификаторы

NCT: NCT07680998 · IDIL/2024/JL01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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