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NCT Number: NCT07687082

Prevalence and Risk Factors for Chronic Post-Surgical Pain Following Video-Assisted Thoracic Surgery : The EVATHO Prospective Bicentric Cohort Study.

Chronic post-surgical pain (CPSP) remains a common complication after thoracic surgery and may significantly impair patients' quality of life. Although the widespread adoption of video-assisted thoracic surgery (VATS) has reduced surgical trauma and improved postoperative recovery, a substantial proportion of patients still develop persistent pain.

The EVATHO study is a multicenter prospective observational cohort designed to determine the prevalence of CPSP three months after VATS and to identify perioperative factors associated with its development. Adult patients undergoing thoracic surgery by VATS at Montpellier and Nice University Hospitals will be prospectively enrolled.

Pain intensity, neuropathic pain characteristics, anxiety, depression, quality of life, and analgesic consumption will be assessed using validated questionnaires during the perioperative period and at 1 and 3 months after surgery. The results of this study may help identify patients at increased risk of CPSP and improve perioperative pain management strategies following thoracic surgery.

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Key information

Conditions

Chronic Post-surgical Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Postoperative Pain After Thoracic Surgery Signs and Symptoms Thoracic Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients undergoing video-assisted thoracic surgery (VATS) for thoracic surgery

Exclusion criteria

  • Age <18 years
  • Adults under legal protection or unable to provide informed non-opposition
  • Patients unable to understand or complete the study questionnaires
  • Patients not affiliated with a French health insurance scheme.
  • Adults under legal protection, including judicial safeguard, guardianship, or curatorship.
  • Participation in another clinical study involving an ongoing exclusion period.
  • Pregnant or breastfeeding women.

Treatment and study plan

Primary outcomes

  1. Number of participants with chronic post-surgical pain

    Time frame: 3 months after surgery.

    Chronic post-surgical pain defined as a Brief Pain Inventory (BPI) average pain score greater than 3 at the 3-month postoperative follow-up.

Secondary outcomes

  1. Postoperative pain at 1 month after VATS

    Time frame: 1 month after thoracic surgery

    Post-surgical pain defined as a Brief Pain Inventory (BPI) average pain score greater than 3 at the 1-month postoperative follow-up.

  2. Visual Analogue Scale (VAS) pain score

    Time frame: Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.

    Pain intensity measured using the Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).

  3. Cumulative postoperative opioid consumption.

    Time frame: Postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.

    Total opioid consumption during the postoperative period as morphine milligram equivalents

  4. Douleur Neuropathie 4 (DN4) score

    Time frame: Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.

    Neuropathic pain measured using the Douleur Neuropathique 4 (DN4) questionnaire. Scores range from 0 to 10, with scores greater than or equal to 4 indicating neuropathic pain.

  5. Hospitalier Anxiety and depression Scale (HADS) anxiety score

    Time frame: Preoperative assessment, 1 month, and 3 months after surgery.

    Anxiety measured using the hospital Anxiety and Depression Scale (HADS-A). Scores range from 0 to 21, with scores greater than or equal to 11 indicating clinically significant anxiety.

  6. Hospital Anxiety and Depression Scale (HADS) depression score

    Time frame: Preoperative assessment, 1 month, and 3 months after surgery

    Depression measured using the Hospital Anxiety and Depression Scale (HADS-D). Scores range from 0 to 21, with scores greater than or equal to 11 indicating clinically significant depression.

  7. Brief Pain Inventory (BPI) pain interference score

    Time frame: 1 month and 3 months after surgery.

    Pain interference with daily activities measured using the Brief Pain Inventory (BPI) interference subscale

  8. Short Form-12 Physical component summary score

    Time frame: Preoperative assessment, 1 month, and 3 months after surgery.

    Physical health-related quality of life measured using the Physical Component Summary (PCS) score of the Short Form-12 (SF-12) questionnaire.

  9. Short form-12 Mental Component Summary score

    Time frame: Preoperative assessment, 1 month and 3 months after surgery

    Mental health-related quality of life measured using the Mental Component Summary (MCS) score of the Short Form-12 (SF-12) questionnaire.

Study contacts

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

Benjamin Bourdois, MD

CONTACT

[email protected]

+33467335958

Sophie Bringuier, MD

CONTACT

+33467335958

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Study of the Prevalence of Chronic Postoperative Pain After Video-Assisted Thoracic Surgery: A Bicentric Cohort Study

Acronym: EVATHO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 7, 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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