Clinical Trial

PABLOS 2.0 - Chronic Pain After Sternotomy

Study acronym: PABLOS2
Recruiting
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Record status
This record was last updated August 26, 2024 (before its estimated August 18, 2025 completion). Its status may not reflect the trial's current state.
Summary
The PABLOS study (NCT05345639) recently realised at the University Hospital of Angers looked at the place of loco-regional anesthesia (LRA) in the optimization of analgesia and the early post-operative recovery of patients operated from cardiac surgery by sternotomy. All randomized patients (n=253) were followed for 30 days as part of PABLOS monitoring with the aim of optimizing acute care. However, sternotomy surgery causes chronic pain with neuropathic components. Indeed, numerous recent studies suggest that cardiac surgery by median sternotomy is associated with the development of chronic sternal pain with an incidence of 11% to 56% one year after surgery. Most patients with chronic post-sternotomies pain report mild pain (1 to 3 on the Numerical Scale), however, up to 18% report moderate to severe pain (4 to 10 on the EN). It therefore seems important to the investigator to evaluate the prevalence of chronic post-sternotomies pain within our PABLOS cohort and to know whether performing a post-operative LRA limits their occurrence.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-07-30; most recent amendment 2024-08-22.
Status change: Not Yet Recruiting → Recruiting 2024-08-22
Trial Details
NCT Number NCT06534775
Lead Sponsor University Hospital, Angers
Conditions Anesthesia
Enrollment 253 participants
Start Date 2024-08-19
Primary Completion 2025-08-18 (estimated)
Study Completion 2025-08-18 (estimated)
Updated on ClinicalTrials.gov 2024-08-26