PABLOS 2.0 - Chronic Pain After Sternotomy

Recruiting now

Conditions studied: Anesthesia

In brief

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.

Key facts

Study ID

NCT06534775

Run by

University Hospital, Angers

People needed

253

Starts

2024-08-19

Expected to finish

2025-08-18

Last updated by the study team

2024-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient who participated in the PABLOS study (See below);
• French-speaking patient, able to understand and answer a questionnary

You may not qualify if…

• 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.

Where it is running

• Dr Achille DEMARQUETTE — Angers, Maine Et Loire, France (enrolling)

Full record on ClinicalTrials.gov

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