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

29 juni 2026 bijgewerkt door: University Hospital, Montpellier

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

400

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Benjamin Bourdois, MD
Telefoonnummer: +33467335958
E-mail: b-bourdois@chu-montpellier.fr

Studie Contact Back-up

Naam: Sophie Bringuier, MD
Telefoonnummer: +33467335958

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Number of participants with chronic post-surgical pain Tijdsspanne: 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.	3 months after surgery.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Postoperative pain at 1 month after VATS Tijdsspanne: 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.	1 month after thoracic surgery
Visual Analogue Scale (VAS) pain score Tijdsspanne: 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).	Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
Cumulative postoperative opioid consumption. Tijdsspanne: Postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.	Total opioid consumption during the postoperative period as morphine milligram equivalents	Postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
Douleur Neuropathie 4 (DN4) score Tijdsspanne: 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.	Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
Hospitalier Anxiety and depression Scale (HADS) anxiety score Tijdsspanne: 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.	Preoperative assessment, 1 month, and 3 months after surgery.
Hospital Anxiety and Depression Scale (HADS) depression score Tijdsspanne: 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.	Preoperative assessment, 1 month, and 3 months after surgery
Brief Pain Inventory (BPI) pain interference score Tijdsspanne: 1 month and 3 months after surgery.	Pain interference with daily activities measured using the Brief Pain Inventory (BPI) interference subscale	1 month and 3 months after surgery.
Short Form-12 Physical component summary score Tijdsspanne: 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.	Preoperative assessment, 1 month, and 3 months after surgery.
Short form-12 Mental Component Summary score Tijdsspanne: 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.	Preoperative assessment, 1 month and 3 months after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Montpellier

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 april 2028

Studie voltooiing (Geschat)

1 augustus 2028

Studieregistratiedata

Eerst ingediend

21 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juni 2026

Eerst geplaatst (Werkelijk)

7 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)