Evaluating Chronic Pain After Heart Surgery

PABLOS 2.0 - Chronic Pain After Sternotomy, Prospective Non-interventional Study

This study looks at how many people still have pain after heart surgery and how it affects their daily lives.

Quick facts

• Study type: Observational
• Enrollment: 253 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Angers (Government)
• Locations: 1 site (Angers, Maine Et Loire)
• Trial ID: NCT06534775 on ClinicalTrials.gov

What this trial studies

PABLOS 2.0 is a non-interventional cohort study that aims to assess the prevalence of chronic pain following sternotomy in patients who previously participated in the PABLOS study. The study involves collecting data through telephone questionnaires to evaluate pain levels, quality of life, and painkiller consumption among these patients. By analyzing the incidence of chronic sternal pain and its neuropathic components, the study seeks to enhance understanding of post-operative recovery in cardiac surgery patients.

Who should consider this trial

Good fit: Ideal candidates are French-speaking adults who have previously undergone cardiac surgery with sternotomy at the Angers University Hospital.

Not a fit: Patients who have had subsequent cardiac or thoracic surgeries after their initial sternotomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for chronic pain in patients after sternotomy.

How similar studies have performed: Previous studies have indicated a significant incidence of chronic pain after sternotomy, suggesting that this area of research is both relevant and necessary.

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.

Where this trial is running

Angers, Maine Et Loire

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

Study contacts

• Study coordinator: Achille DEMARQUETTE, Dr

Conditions Anesthesia