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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07687082
Acronym
EVATHO
Enrollment
400
Registered
2026-07-07
Start date
2026-08-01
Completion date
2028-08-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Post-surgical Pain, Neuropathic Pain, Postoperative Pain After Thoracic Surgery, Thoracic Surgical Procedures

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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with chronic post-surgical pain3 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

MeasureTime frameDescription
Postoperative pain at 1 month after VATS1 month after thoracic surgeryPost-surgical pain defined as a Brief Pain Inventory (BPI) average pain score greater than 3 at the 1-month postoperative follow-up.
Visual Analogue Scale (VAS) pain scorePreoperative 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).
Cumulative postoperative opioid consumption.Postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.Total opioid consumption during the postoperative period as morphine milligram equivalents
Douleur Neuropathie 4 (DN4) scorePreoperative 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.
Hospitalier Anxiety and depression Scale (HADS) anxiety scorePreoperative 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.
Hospital Anxiety and Depression Scale (HADS) depression scorePreoperative assessment, 1 month, and 3 months after surgeryDepression 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.
Brief Pain Inventory (BPI) pain interference score1 month and 3 months after surgery.Pain interference with daily activities measured using the Brief Pain Inventory (BPI) interference subscale
Short Form-12 Physical component summary scorePreoperative 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.
Short form-12 Mental Component Summary scorePreoperative assessment, 1 month and 3 months after surgeryMental health-related quality of life measured using the Mental Component Summary (MCS) score of the Short Form-12 (SF-12) questionnaire.

Contacts

CONTACTBenjamin Bourdois, MD
b-bourdois@chu-montpellier.fr+33467335958
CONTACTSophie Bringuier, MD
+33467335958

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026