Prevalence and Risk Factors for Chronic Post-Surgical Pain Following Video-Assisted Thoracic Surgery : The EVATHO Prospective Bicentric Cohort Study. (EVATHO)
29. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Observasjonsmessig
Registrering (Antatt)
400
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Benjamin Bourdois, MD
- Telefonnummer: +33467335958
- E-post: b-bourdois@chu-montpellier.fr
Studer Kontakt Backup
- Navn: Sophie Bringuier, MD
- Telefonnummer: +33467335958
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
1. april 2028
Studiet fullført (Antatt)
1. august 2028
Datoer for studieregistrering
Først innsendt
21. juni 2026
Først innsendt som oppfylte QC-kriteriene
29. juni 2026
Først lagt ut (Faktiske)
7. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RECHMPL 25_0555
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