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

NCT07680998 | Recruiting

• 1 other identifier: IDIL/2024/JL01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Post Operative Pain

Keywords

Post Operative Pain; Pain Management; Monitoring

Outcome Measures

Primary Outcomes (2)

• Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group

  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

  Day 2

• Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the standard care (control) group.

  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

  Day 2

Secondary Outcomes (105)

• 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

Study Arms (2)

Postoperative pain management : standard care

NO INTERVENTION

Patients receiving standard postoperative analgesic care

Postoperative pain management using the Thess telemonitoring device

EXPERIMENTAL

Patients being monitored with the Thess Monitoring medical telemonitoring device in conjunction with the ANTALGEEK® protocol

Device: Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol

Interventions

Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol DEVICE

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 postoperative recovery during the first week. The ANTALGEEK decision-making algorithm and a medical telemonitoring protocol help patients follow their pain medication regimen, monitoring them in postoperative Week 1, based on the preoperative prescription, data on the patient's adherence to treatment, its efficacy and tolerability.

Postoperative pain management using the Thess telemonitoring device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nimes University Hospital

Nîmes, Gard, 30029, France

RECRUITING

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MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Joël LHERMITE, Dr.

CONTACT

+334.66.68.30.50; joel.lhermite@chu-nimes.fr

Anissa MEGZARI

CONTACT

0466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (open-label).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, single-center, randomized controlled trial (1:1 ratio) conducted as an open-label study comparing two management approaches: postoperative pain monitoring using the Thess Monitoring medical telemonitoring device in combination with the ANTALGEEK® protocol (experimental group) versus standard of care (control group).

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: December 1, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)