Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

29. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

Navn: Sophie Bringuier, MD
Telefonnummer: +33467335958

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Number of participants with chronic post-surgical pain Tidsramme: 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.

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Postoperative pain at 1 month after VATS Tidsramme: 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 Tidsramme: 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. Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Montpellier

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

21. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)