Effectiveness of the transverse thoracic muscle plane block in adult cardiac surgery: a double-blind randomized clinical trial
Descrizione riassuntiva dello studio
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)
Intervento studiato
- 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)
Malattie studiate
- 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)
Criteri di esclusione
- Emergent cardiac surgery - Previous cardiac surgery - Known hypersensitivity or true allergy to bupivacaine and other amide-class LA (BASEC)
Luogo dello studio
Losanna
(BASEC)
Sponsor
CHUV
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Etienne Revelly
+41795569990
etienne.revelly@clutterchuv.chCHUV 1011 Lausanne
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
28.10.2022
(BASEC)
ID di studio ICTRP
NCT05681507 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Efficacy of TTMPB in Adult Cardiac Surgery (BASEC)
Titolo accademico
Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial (ICTRP)
Titolo pubblico
Efficacy of TTMPB in Adult Cardiac Surgery (ICTRP)
Malattie studiate
Acute Post Operative Pain (ICTRP)
Intervento studiato
Drug: Transversus thoracic muscle plane block;Procedure: Standard postoperative analgesia (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
Total amount (in mg) of opioid consumption within the first 24 hours (ICTRP)
non disponibile
Data di registrazione
13.12.2022 (ICTRP)
Inclusione del primo partecipante
01.12.2022 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
TTMPB-Heart Trial (2022-01126) (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/show/NCT05681507 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile