Clinical trial NCT06534775: PABLOS 2.0 - Chronic Pain After Sternotomy
Official title: PABLOS 2.0 - Chronic Pain After Sternotomy, Prospective Non-interventional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-08-02
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the PABLOS study, without non-inclusion criteria, are pre-selected to participate in the study. These are patients from the original PABLOS study who underwent thoracic surgery by sternotomy at the Angers University Hospital. The PABLOS inclusion period extended from August 1, 2022 to August 2, 2023.

Patients receive an information letter at home, containing all the information relating to the PABLOS 2.0 study, a few weeks before receiving a telephone call, as well as a booklet containing the questionnary. From this stage, the patient has the possibility of contacting the team to express their opposition to participating in the study.

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.

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 blinded for the duration of the study.

The patients in the cohort come from the precedent PABLOS study (NCT05345639). They receive oral and written information, and confirm orally their non-opposition to participating in the PABLOS 2.0 study.

The specific procedures of the PABLOS 2.0 study are the collection using a telephone questionnary of the score of the numerical scale (from 0 to 10) of pain at rest and with effort, of the DN4 (proportion of chronic pain with a neuropathic component), of the EQ-5D-5L scale (quality of life) and of consumption of painkillers.

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.

Primary outcomes:
measure: Effectiveness of LRA
timeFrame: 12 to 24 months
Secondary outcomes:
measure: LRA Impact on the intensity of exercise pain
timeFrame: 12 to 24 months
measure: LRA Impact on the prevalence of neuropathic pain
timeFrame: 12 to 24 months
measure: LRA Impact on daily consumption of analgesics
timeFrame: 12 to 24 months
measure: LRA Impact on quality of life
timeFrame: 12 to 24 months
measure: To describe all-cause mortality in cardiac surgery patients
timeFrame: 12 to 24 months
measure: Infection of the puncture point(s) event in context of LRA in the long term.
timeFrame: 12 to 24 months
measure: sternotomy scar revision in context of LRA in the long term.
timeFrame: 12 to 24 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Dr Achille DEMARQUETTE
state: Maine Et Loire
Study officials:
References: