NCT06534775 PABLOS 2.0 - Chronic Pain After Sternotomy
| NCT ID | NCT06534775 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Anesthesia |
| Study Type | OBSERVATIONAL |
| Enrollment | 253 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2025-08-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 253 participants in total. It began in 2024-08-19 with a primary completion date of 2025-08-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06534775 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06534775 currently recruiting?
Yes, NCT06534775 is actively recruiting participants. Contact the research team at achille.demarquette@chu-angers.fr for enrollment information.
Where is the NCT06534775 trial being conducted?
This trial is being conducted at Angers, France.
Who is sponsoring the NCT06534775 clinical trial?
NCT06534775 is sponsored by University Hospital, Angers. The trial plans to enroll 253 participants.