- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07687082
Prevalence and Risk Factors for Chronic Post-Surgical Pain Following Video-Assisted Thoracic Surgery : The EVATHO Prospective Bicentric Cohort Study. (EVATHO)
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Benjamin Bourdois, MD
- Phone Number: +33467335958
- Email: b-bourdois@chu-montpellier.fr
Study Contact Backup
- Name: Sophie Bringuier, MD
- Phone Number: +33467335958
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with chronic post-surgical pain
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain at 1 month after VATS
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL 25_0555
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuropathic Pain
-
Unity Health TorontoRecruitingChronic Neuropathic PainCanada
-
University Hospital, Clermont-FerrandFondation ApicilCompletedNeuropathic Traumatic Pain | Pain NRS ≥ 4 | Peripheral Neuropathic Pain | Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4France
-
Pontificia Universidad Catolica de ChileNot yet recruiting
-
Poitiers University HospitalRecruitingChronic Neuropathic PainFrance
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPostherpetic Neuralgia (PHN) | Chemotherapy Induced Neuropathic Pain | Diabetic Peripheral Neuropathic Pain (DPN) | HIV-related Neuropathic Pain (HIV)Colombia, Mexico, Ecuador, Peru, Venezuela
-
Eli Lilly and CompanyRecruitingDiabetic Peripheral Neuropathic PainUnited States, Puerto Rico
-
Shandong Suncadia Medicine Co., Ltd.RecruitingDiabetic Peripheral Neuropathic PainChina
-
Shanghai Yidian Pharmaceutical Technology Development...Not yet recruitingDiabetic Peripheral Neuropathic Pain
-
Ente Ospedaliero Ospedali GallieraCompletedNeuropathic Pain in CancerItaly
-
Ibadat International University, IslamabadNot yet recruiting