CompletedPhase 3Other

Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)

NCT ID

NCT05345639

Target Enrollment

254 participants

Start Date

2022-08-01

Est. Completion

2023-09-07

About This Study

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.

Conditions Studied

Pain, PostoperativeCardiac Surgery

Interventions

•LRA Loco-regional anesthesia
•Standardized post-operative analgesia protocol

Eligibility

Age:18 Years - 100 Years

Healthy Volunteers:No

View full eligibility criteria

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.

Study Locations (1)

Jeanneteau

Angers, maine et loire, France