Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study) (NCT05345639) | Clinical Trial Compass
CompletedPhase 3
Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)
France254 participantsStarted 2022-08-01
Plain-language summary
The main objective is to compare the effectiveness of LocoRegional Anesthesia (LRA) (bilateral transverse thoracic block or bilateral parasternal block) in addition to standard management compared to standard management alone (general anesthesia without LRA) on the FQoR-15 (French Quality of Recovery - 15 score) at H+24 after cardiac surgery by sternotomy.This is a phase III monocentric superiority study , comparative, with three parallel groups, randomized with a ratio (1:1:1), controlled versus standard management, single-blind.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pre-inclusion criteria :
* Adult patient (≥18 years old);
* Patient having scheduled cardiac surgery with a sternotomy performed at the CHU d'Angers;
* Patient having signed a consent;
* French-speaking patient, able to understand and answer a questionnaire;
* Affiliated patient or beneficiary of a social security scheme.
Criteria for confirming inclusion
* Hemodynamic stability at the end of surgery;
* Absence of bleeding justifying immediate revision surgery.
Non-inclusion criteria
* Known hypersensitivity to amide-bonded local anesthetics;
* Operation for cardiac revision surgery, including sternotomy REDUX (revision surgery);
* Emergency surgery;
* Surgery in a septic context (Endocarditis, Intravascular device infection);
* Weight less than 30kg;
* Severe psychiatric or cognitive impairment interfering with assessment by questionnaires;
* Pregnant, breastfeeding or parturient woman;
* Person deprived of liberty by judicial or administrative decision;
* A person undergoing psychiatric treatment under duress;
* Person subject to a measure of legal protection;
* Inclusion in another interventional study modifying postoperative pain management.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
FQoR-15 score at 24 hours (French Quality of Recovery-15 score)