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

NCT05345639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Cardiac 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.

Sponsors & Collaborators

  • Fondation Apicil

    collaborator OTHER

  • University Hospital, Angers

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-08-08
Completion
2023-09-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345639 on ClinicalTrials.gov