Status:
COMPLETED
Chest Wall Block After Sternotomy: Randomized Controlled Trial in Cardiac Surgery: (PABLOS Study)
Lead Sponsor:
University Hospital, Angers
Collaborating Sponsors:
Fondation Apicil
Conditions:
Pain, Postoperative
Cardiac Surgery
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Each year, more than one million patients worldwide undergo cardiac surgery via sternotomy. Postoperative pain is frequent in this context, affecting 49% of patients at rest and 78% during mobilizatio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2023
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT05345639
Start Date
August 1 2022
End Date
September 7 2023
Last Update
March 21 2025
Active Locations (1)
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1
Jeanneteau
Angers, maine et loire, France, 49933