Clinical trial NCT05681507: Efficacy of TTMPB in Adult Cardiac Surgery
Official title: Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Post Operative Pain
Keywords: Transversus Thoracic Muscle Plane Block
Adult Cardiac Surgery
Sternotomy
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficacy of Transversus Thoracic Muscle Plane Block (TTMPB) integrated in a modern multimodal analgesia protocol, following the ERAS® recommendations, in adult patients undergoing planned open heart surgery.

The main study question is:

Does the addition of TTMPB to a standard analgesic protocol significantly improve analgesia following elective open heart surgery?

The investigators will primarily compare postoperative opioid consumption and pain scores in patients who will be randomly allocated to one of two groups:

The control group will receive standard analgesia per institutional Intensive Care Unit protocol.

The intervention group will receive the same standard of care plus a TTMP block (40ml of bupivacaine 0.375%, total dose of 150 mg).

The investigators will also study the impact of group allocation on secondary outcomes, such as the rate of early mobilization.


Eligibility criteria: 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)

Primary outcomes:
measure: Total amount (in mg) of opioid consumption within the first 24 hours
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUVaudois
state: VD
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Valentina Rancati, Attending physician
role: PRINCIPAL_INVESTIGATOR
References: