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PABLOS 2.0 - Chronic Pain After Sternotomy

Study acronym: PABLOS2
StatusUnknown
PhaseNot specified
Started2024-08-19
View on ClinicalTrials.gov ↗
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.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2024-08-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Unknown
Primary completion date2025-07-31→2025-08-18
Completion date2025-07-31→2025-08-18
Start dateestimated 2024-08-01→confirmed 2024-08-19
Study sites0→1
2024-08-05
minor
Study Status, Study Description, Outcome Measures v2
Secondary endpointsdetails revised at 2 of 7 entries
2024-08-01
minor
Study Status, Outcome Measures v1
Secondary endpoints6 to 7 entries
The safetyInfection of performingthe puncture point(s) event in context of LRA in the long term. sternotomy scar revision in context of LRA in the long term.
2024-07-30
minor
Original filing
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.
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