Status:
RECRUITING
PABLOS 2.0 - Chronic Pain After Sternotomy
Lead Sponsor:
University Hospital, Angers
Conditions:
Anesthesia
Eligibility:
All Genders
18+ years
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-operativ...
Detailed Description
PABLOS 2.0 is a non-interventional cohort study with prospective data collection by telephone questionnary, with three groups from a single-center superiority interventional study. Patients remained b...
Eligibility Criteria
Inclusion
- Patient who participated in the PABLOS study (See below);
- French-speaking patient, able to understand and answer a questionnary
Exclusion
- 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.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 18 2025
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT06534775
Start Date
August 19 2024
End Date
August 18 2025
Last Update
August 26 2024
Active Locations (1)
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1
Dr Achille DEMARQUETTE
Angers, Maine Et Loire, France, 49933