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

PHASE3CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

August 1, 2022

Primary Completion Date

August 8, 2023

Study Completion Date

September 7, 2023

Conditions
Pain, PostoperativeCardiac Surgery
Interventions
DRUG

LRA Loco-regional anesthesia

"Bilateral parasternal block or transverse thoracic block are performed ultrasound-guided, at the end of surgery in the operating room. Once in the desired plane depending on the randomisation (transverse or parasternal), a volume of 20 ml of ropivacaine at 2 mg/ml is injected on each side of the sternum.~The intervention (TTP or PSB) is performed by the anesthetist-resuscitator investigator."

PROCEDURE

Standardized post-operative analgesia protocol

"The pain management protocol in intensive care is as follows:~* paracetamol 1g x 4 per day systematically (apart from the usual contraindications), IV then PO;~* PCA (Patient Controlled Analgesia) with oxycodone or morphine: 1mg bolus, 7min refractory period, maximum 4h dose 20mg.~The PCA is usually maintained until 24-48h after the intervention then relayed by oxycodone 5mg every 4h if EVA \> 3 sublingual and addition of oxycodone LP 10mg x 2 per day if daily intake on PCA \> 20mg.~Remedy molecules in case of ineffective analgesia:~ketoprofen 100mg q12h IV, or 50mg q8h PO; nefopam 20mg every 6h IV or PO; ketamine 1 to 1.5 mg/kg/24H IVSE."

Trial Locations (1)

49933

Jeanneteau, Angers

All Listed Sponsors
collaborator

Fondation Apicil

OTHER

lead

University Hospital, Angers

OTHER_GOV