Skip to content

Evaluation of the Impact of a Strategy of Perioperative NSAID Suppression in Patients Undergoing Video-assisted Thoracic Surgery (VATS) on the Presence of Chronic Postoperative Pain (CPOP): a Randomised Clinical Trial (EVADRAINS)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524917-96-00
Enrollment
318
Registered
2026-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-31

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

Conditions

Thoracic surgery

Brief summary

Assessment of Postoperative Pain at 3 Months Using a Numerical Rating Scale (NRS)

Detailed description

1. The maximum pain score at rest and the maximum pain score during movement, assessed using the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable), at Day 0 in the post-anesthesia care unit (PACU), Day 1, Day 3, Month 1, and Month 3 postoperatively., 2. The score obtained from the DN4 questionnaire at Day 1, Day 3, Month 1, and Month 3 (a score ≥ 4 indicates neuropathic pain)., 3. The cumulative amount (in mg morphine equivalents) of opioids administered intraoperatively, in the PACU, at Day 1, at Day 3, and then from Day 0 to 1 month and from Day 0 to 3 months after surgery., 4. The number of hospitalization days for patients in the two groups., 5. The scores obtained from the QoR-15 questionnaire and from the physical and mental components of the SF-36 at inclusion, and at 1 and 3 months after surgery., 6. Collection of adverse events and serious adverse events., 7. Global proteomic and transcriptomic (RNA-seq) analysis and targeted analysis by RT-qPCR on blood samples at Day 0, Day 1, and Month 3 after surgery., 8. Blood tests for complete blood count (CBC) and C-reactive protein (CRP) as part of routine care, supplemented by research analysis of S100 A8/A9 protein and interleukin-6 on blood samples collected at Day 0, Day 1, and Month 3 after surgery., Collection of data on non-opioid analgesic use intraoperatively, in the post-anesthesia care unit (PACU), on postoperative days 1 and 3, and cumulatively from day 0 to 1 month and from day 0 to 3 months after surgery.

Interventions

DRUGGélules Kétoprofène 100 mg LP
DRUGsolution pour perfusion
DRUGCalcium (hydrogénophosphate dihydraté)
DRUGsolution à diluer pour perfusion
DRUGSODIUM CHLORIDE

Sponsors

Les Hopitaux Universitaires De Strasbourg
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Assessment of Postoperative Pain at 3 Months Using a Numerical Rating Scale (NRS)

Secondary

MeasureTime frame
1. The maximum pain score at rest and the maximum pain score during movement, assessed using the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable), at Day 0 in the post-anesthesia care unit (PACU), Day 1, Day 3, Month 1, and Month 3 postoperatively., 2. The score obtained from the DN4 questionnaire at Day 1, Day 3, Month 1, and Month 3 (a score ≥ 4 indicates neuropathic pain)., 3. The cumulative amount (in mg morphine equivalents) of opioids administered intraoperatively, in the PACU, at Day 1, at Day 3, and then from Day 0 to 1 month and from Day 0 to 3 months after surgery., 4. The number of hospitalization days for patients in the two groups., 5. The scores obtained from the QoR-15 questionnaire and from the physical and mental components of the SF-36 at inclusion, and at 1 and 3 months after surgery., 6. Collection of adverse events and serious adverse events., 7. Global proteomic and transcriptomic (RNA-seq) analysis and targeted analysis by RT-qPCR on blood sa

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 1, 2026