Effectiveness of the transverse thoracic muscle plane block in adult cardiac surgery: a double-blind randomized clinical trial
Résumé de l'étude
Patients undergoing heart surgery via sternotomy experience moderate to severe pain after the operation, which may increase the dose of potent painkillers (morphine and derivatives) that have frequent side effects (nausea, vomiting, itching, respiratory failure). Furthermore, the management of high-dose administration occurs in an intensive care setting. This represents a barrier to rapid recovery and mobilization. In recent years, new techniques of locoregional anesthesia have been described for the treatment of post-operative pain. One of these techniques (transverse thoracic muscle plane block) is currently used at CHUV, but there are currently no data demonstrating its benefit in a larger patient cohort. We therefore wish to compare this technique to the so-called usual management.
(BASEC)
Intervention étudiée
- Effectiveness of adding locoregional anesthesia - the transverse thoracic muscle plane block - in addition to general anesthesia for patients benefiting from elective cardiac surgery with sternotomy
(BASEC)
Maladie en cours d'investigation
- Adult patient requiring elective cardiac surgery with sternum incision (sternotomy) under general anesthesia
(BASEC)
- Direct informed consent as documented by signature - Major adult (≥ 18 years old) with body weight ≥ 50 kg. For the record, fifty kilograms is the minimal weight to ensure that participants remain safely away from maximal doses of LA (3 mg/kg) - Planned and primary cardiac surgery via a sternotomy approach - Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum two hours) (BASEC)
Critères d'exclusion
- Emergent cardiac surgery - Previous cardiac surgery - Known hypersensitivity or true allergy to bupivacaine and other amide-class LA (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Etienne Revelly
+41795569990
etienne.revelly@clutterchuv.chCHUV 1011 Lausanne
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
28.10.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05681507 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Efficacy of TTMPB in Adult Cardiac Surgery (BASEC)
Titre académique
Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial (ICTRP)
Titre public
Efficacy of TTMPB in Adult Cardiac Surgery (ICTRP)
Maladie en cours d'investigation
Acute Post Operative Pain (ICTRP)
Intervention étudiée
Drug: Transversus thoracic muscle plane block;Procedure: Standard postoperative analgesia (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Direct informed consent as documented by signature
- Major adult (= 18 years old) with body weight = 50 kg. For the record, fifty kilograms
is the minimal weight to ensure that participants remain safely away from maximal
doses of LA (3 mg/kg)
- Planned and primary cardiac surgery via a sternotomy approach
- Planned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum
two hours)
Exclusion Criteria:
- Participation in another study with investigational drug within the 30 days preceding
and during the present study
- Refusal and/or inability to understand or sign the informed consent
- Emergent cardiac surgery
- Previous cardiac surgery
- Known hypersensitivity or true allergy to bupivacaine and other amide-class LA
- Chronic pain history
- Substance abuse history
- Inability to follow the procedures of the study (e.g. due to language problems,
psychological / psychiatric disorders, dementia)
- Clinically significant concomitant diseases: severe cardiac dysfunction (i.e. LVEF =
35%); severe chronic obstructive pulmonary disease (i.e. FEV < 50%); severe hepatic
disease.
- Severe obesity (BMI > 35kg/m2)
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Total amount (in mg) of opioid consumption within the first 24 hours (ICTRP)
non disponible
Date d'enregistrement
13.12.2022 (ICTRP)
Inclusion du premier participant
01.12.2022 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
TTMPB-Heart Trial (2022-01126) (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/show/NCT05681507 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible