PABLOS 2.0 - Chronic Pain After Sternotomy
Unknown statusNCT06534775
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- PABLOS 2.0 - Chronic Pain After Sternotomy, Prospective Non-interventional Study
- Conditions
- Interventions
- Other: Questionnary
- Sponsor
- University Hospital, Angers
- Start date
- 2024-08-19
- Primary completion
- 2025-08-18
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient who participated in the PABLOS study (See below); * French-speaking patient, able to understand and answer a questionnary Exclusion Criteria: * Patient who has had an operation for cardiac or thoracic surgery, including a REDUX (surgical revision) of sternotomy since their inclusion in the PABLOS study; * Patient opposing the research. PABLOS criteria (NCT05345639) : Pre-inclusion criteria * Adult patient (≥18 years old); * Patient having planned cardiac surgery with performance of a sternotomy at the Angers University Hospital; * Patient having signed consent; * French-speaking patient, able to understand and answer a questionnary; * Patient affiliated to or beneficiary of a social security scheme; Criteria for confirming inclusion * Hemodynamic stability at the end of surgical intervention; * Absence of bleeding justifying immediate surgical revision Non-inclusion criteria * Known hypersensitivity to local anesthetics with amide bonds; * Operation for cardiac surgical revision, including REDUX (surgical revision) of sternotomy; * Emergency surgery; * Surgery in a septic context (Endocarditis, Intravascular device infection); * Weight less than 30kg; * Severe psychiatric or cognitive disorder hindering assessment by questionnary; * Pregnant, breastfeeding or parturient woman; * Person deprived of liberty by judicial or administrative decision; * Person subject to psychiatric care under duress; * Person subject to a legal protection measure; * Inclusion in another interventional study modifying post-operative pain management.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06534775