NCT07687082

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

June 21, 2026

Last Update Submit

June 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with chronic post-surgical pain

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

    3 months after surgery.

Secondary Outcomes (9)

  • Postoperative pain at 1 month after VATS

    1 month after thoracic surgery

  • Visual Analogue Scale (VAS) pain score

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

  • Cumulative postoperative opioid consumption.

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

  • Douleur Neuropathie 4 (DN4) score

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

  • Hospitalier Anxiety and depression Scale (HADS) anxiety score

    Preoperative assessment, 1 month, and 3 months after surgery.

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing video-assisted thoracic surgery (VATS) for pulmonary resection, pleural procedures, chest wall surgery, or lung biopsy at Montpellier and Nice University Hospitals.

You may qualify if:

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

You may not qualify if:

  • 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.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeNeuralgia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Benjamin Bourdois, MD

CONTACT

Sophie Bringuier, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2026

First Posted

July 7, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share