Effectiveness of the transverse thoracic muscle plane block in adult cardiac surgery: a double-blind randomized clinical trial
Zusammenfassung der Studie
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)
Untersuchte Intervention
- 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)
Untersuchte Krankheit(en)
- 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)
Ausschlusskriterien
- Emergent cardiac surgery - Previous cardiac surgery - Known hypersensitivity or true allergy to bupivacaine and other amide-class LA (BASEC)
Studienstandort
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Etienne Revelly
+41795569990
etienne.revelly@clutterchuv.chCHUV 1011 Lausanne
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
28.10.2022
(BASEC)
ICTRP Studien-ID
NCT05681507 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Efficacy of TTMPB in Adult Cardiac Surgery (BASEC)
Wissenschaftlicher Titel
Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial (ICTRP)
Öffentlicher Titel
Efficacy of TTMPB in Adult Cardiac Surgery (ICTRP)
Untersuchte Krankheit(en)
Acute Post Operative Pain (ICTRP)
Untersuchte Intervention
Drug: Transversus thoracic muscle plane block;Procedure: Standard postoperative analgesia (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Total amount (in mg) of opioid consumption within the first 24 hours (ICTRP)
nicht verfügbar
Registrierungsdatum
13.12.2022 (ICTRP)
Einschluss des ersten Teilnehmers
01.12.2022 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
TTMPB-Heart Trial (2022-01126) (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/show/NCT05681507 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar