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NCT Number: NCT07680998

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

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.

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Key information

Conditions

Post Operative Pain Agnosia Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  1. Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group

    Time frame: Day 1, before the intervention

    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

  2. Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group

    Time frame: Day 1, after the intervention

    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

  3. Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group

    Time frame: Day 7

    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

  4. Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group

    Time frame: Day 1, before the intervention

    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

  5. Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group

    Time frame: Day 1, after the intervention

    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

  6. Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group

    Time frame: Day 7

    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

  7. Pain progression in the experimental group

    Time frame: Day 1

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  8. Pain progression in the experimental group

    Time frame: Day 2

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  9. Pain progression in the experimental group

    Time frame: Day 3

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  10. Pain progression in the experimental group

    Time frame: Day 4

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  11. Pain progression in the experimental group

    Time frame: Day 5

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  12. Pain progression in the experimental group

    Time frame: Day 6

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  13. Pain progression in the experimental group

    Time frame: Day 7

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  14. Pain progression in the experimental group

    Time frame: Month 1

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  15. Pain progression in the experimental group

    Time frame: Month 2

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  16. Pain progression in the experimental group

    Time frame: Month 3

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  17. Pain progression in the in the standard care (control) group

    Time frame: Day 1

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  18. Pain progression in the in the standard care (control) group

    Time frame: Day 2

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  19. Pain progression in the in the standard care (control) group

    Time frame: Day 3

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  20. Pain progression in the in the standard care (control) group

    Time frame: Day 4

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  21. Pain progression in the in the standard care (control) group

    Time frame: Day 5

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  22. Pain progression in the in the standard care (control) group

    Time frame: Day 6

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  23. Pain progression in the in the standard care (control) group

    Time frame: Day 7

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  24. Pain progression in the in the standard care (control) group

    Time frame: Month 1

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  25. Pain progression in the in the standard care (control) group

    Time frame: Month 2

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  26. Pain progression in the in the standard care (control) group

    Time frame: Month 3

    Average pain score over 24 hours according to the Visual Analog Scale (0 -10)

  27. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group

    Time frame: Baseline

    Patient's declaration in the Thess Monitoring Application

  28. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group

    Time frame: Baseline

    Phone call from the patient

  29. rate of adherence to the standard pain management regimen (non-opioid analgesics) in the in the standard care (control) group

    Time frame: Day 1

    Phone call from the patient

  30. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group

    Time frame: Day 2

    Patient's declaration in the Thess Monitoring Application

  31. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group

    Time frame: Day 2

    Phone call from the patient

  32. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group

    Time frame: Day 3

    Patient's declaration in the Thess Monitoring Application

  33. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group

    Time frame: Day 3

    Phone call from the patient

  34. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group

    Time frame: Day 4

    Patient's declaration in the Thess Monitoring Application

  35. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group

    Time frame: Day 4

    Phone call from the patient

  36. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group

    Time frame: Day 5

    Patient's declaration in the Thess Monitoring Application

  37. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group

    Time frame: Day 5

    Phone call from the patient

  38. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group

    Time frame: Day 6

    Patient's declaration in the Thess Monitoring Application

  39. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group

    Time frame: Day 6

    Phone call from the patient

  40. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group

    Time frame: Day 7

    Patient's declaration in the Thess Monitoring Application

  41. Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group

    Time frame: Day 7

    Phone call from the patient

  42. Incidence of adverse effects associated with opioid use in the experimental group

    Time frame: Baseline

    Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  43. Incidence of adverse effects associated with opioid use in the standard care (control) group

    Time frame: Baseline

    Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  44. Incidence of adverse effects associated with opioid use in the experimental group

    Time frame: Day 1

    Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  45. Incidence of adverse effects associated with opioid use in the standard care (control) group

    Time frame: Day 1

    Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  46. Incidence of adverse effects associated with opioid use in the experimental group

    Time frame: Day 2

    Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  47. Incidence of adverse effects associated with opioid use in the standard care (control) group

    Time frame: Day 2

    Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  48. Incidence of adverse effects associated with opioid use in the experimental group

    Time frame: Day 3

    Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  49. Incidence of adverse effects associated with opioid use in the standard care (control) group

    Time frame: Day 3

    Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  50. Incidence of adverse effects associated with opioid use in the experimental group

    Time frame: Day 4

    Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  51. Incidence of adverse effects associated with opioid use in the standard care (control) group

    Time frame: Day 4

    Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  52. Incidence of adverse effects associated with opioid use in the experimental group

    Time frame: Day 5

    Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  53. Incidence of adverse effects associated with opioid use in the standard care (control) group

    Time frame: Day 5

    Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  54. Incidence of adverse effects associated with opioid use in the experimental group

    Time frame: Day 6

    Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  55. Incidence of adverse effects associated with opioid use in the standard care (control) group

    Time frame: Day 6

    Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  56. Incidence of adverse effects associated with opioid use in the experimental group

    Time frame: Day 7

    Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  57. Incidence of adverse effects associated with opioid use in the standard care (control) group

    Time frame: Day 7

    Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no

  58. Adverse Events [Safety and Tolerability] in the experimental group

    Time frame: Day 7

    Qualitative assessment. Any adverse events of any cause related to treatment will be recorded in the electronic clinical registration form following a phone call to the patient.

  59. Adverse Events [Safety and Tolerability]in the standard care (control) group

    Time frame: Day 7

    Qualitative assessment. Any adverse events of any cause related to treatment will be recorded in the electronic clinical registration form following a phone call to the patient.

  60. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Day 1

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application

  61. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Day 1

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form

  62. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Day 2

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application

  63. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Day 2

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical monitoring form

  64. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Day 3

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application

  65. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Day 3

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form

  66. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Day 4

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.

    Data collection via the Tess Monitoring Application

  67. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Day 4

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form

  68. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Day 5

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.

    Data collection via the Tess Monitoring Application

  69. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Day 5

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form

  70. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Day 6

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application

  71. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Day 6

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form

  72. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Day 7

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application

  73. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Day 7

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical monitoring form

  74. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Month 1

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application and a phone call to the patient

  75. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Month 1

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form and a phone call to the patient

  76. Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group

    Time frame: Month 3

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application and a phone call to the patient

  77. Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group

    Time frame: Month 3

    Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form and a phone call to the patient

  78. Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group

    Time frame: Day 1

    Data collection via the Tess Monitoring Application

  79. Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group

    Time frame: Day 1

    Data collection on the electronic clinical registration form

  80. Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group

    Time frame: Day 2

    Data collection via the Tess Monitoring Application

  81. Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group

    Time frame: Day 2

    Data collection on the electronic clinical registration form

  82. Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group

    Time frame: Day 3

    Data collection via the Tess Monitoring Application

  83. Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group

    Time frame: Day 3

    Data collection on the electronic clinical registration form

  84. Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group

    Time frame: Day 4

    Data collection via the Tess Monitoring Application

  85. Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group

    Time frame: Day 4

    Data collection on the electronic clinical registration form

  86. Prescription issued outside of those prescribed upon hospital discharge in the experimental group

    Time frame: Month 3

    Quantitative

  87. Prescription issued outside of those prescribed upon hospital discharge in the standard care(control) group

    Time frame: Month 3

    Quantitative

  88. Number of days of sick leave prescribed in the experimental group

    Time frame: Month 3

    Quantitative

  89. Number of days of sick leave prescribed in the standard care (control) group

    Time frame: Month 3

    Quantitative

  90. Satisfaction questionnaire administered to the patient in the experimental group

    Time frame: Day 3

    Qualitative

  91. Satisfaction questionnaire administered to the patient in the standard care (control) group

    Time frame: Day 3

    Qualitative

  92. Satisfaction questionnaire administered to the anesthesiologist in the experimental group

    Time frame: End of the inclusion period

    Qualitative

  93. Satisfaction questionnaire administered to the anesthesiologist in the standard care (control) group

    Time frame: End of the inclusion period

    Qualitative

  94. System Usability Scale score during the follow-up call to patients in the experimental group

    Time frame: Day 30

    The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.

  95. System Usability Scale score from health providers to the experimental group

    Time frame: End of the inclusion period

    The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.

  96. System Usability Scale score during the follow-up call to patients in the standard care (control) group

    Time frame: Day 30

    The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.

  97. System Usability Scale score from health providers to the standard care (control) group

    Time frame: End of the inclusion period

    The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.

  98. DN2 questionnaire score in the experimental group

    Time frame: Post-operative Month 1

    The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.

  99. DN2 questionnaire score in the experimental group

    Time frame: Post-operative Month 2

    The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.

  100. DN2 questionnaire score in the experimental group

    Time frame: Post-operative Month 3

    The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.

  101. DN2 questionnaire score in the standard care (control) group

    Time frame: Post-operative Month 1

    The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.

  102. DN2 questionnaire score in the standard care (control) group

    Time frame: Post-operative Month 2

    The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.

  103. DN2 questionnaire score in the standard care (control) group

    Time frame: Post-operative Month 3

    The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.

  104. Rate of incidents, malfunctions, and organization deviations that occurred during implementation in the experimental group

    Time frame: Month 3

    Qualitative

  105. Time spent connected to the Thess Monitoring device per patient in the experimental group

    Time frame: Month 3

    Quantitative, in minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

0466684236

Joël LHERMITE, Dr.

CONTACT

[email protected]

+334.66.68.30.50

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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.

Acronym: TRACE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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