Efficacy of TTMPB in Adult Cardiac Surgery

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to compare the efficacy of Transversus Thoracic Muscle Plane Block (TTMPB) integrated in a modern multi-modal analgesia protocol, following the ERAS® recommendations, in adult patients undergoing planned cardiac surgery with sternotomy.

The main question it aims to answer is:

• Does addition of TTMPB to our analgesia protocol provides better postoperative pain relief than standard of care alone ? This study will consist of two groups. The control group will benefit of standard of care in the form of an institutional Intensive Care Unit-revisited analgesia protocol. The intervention group will benefit of TTMP block with 40ml of bupivacaine 0.375% (dose of 150 mg) and standard of care in the form of an institutional Intensive Care Unit-revisited protocol.

Researchers will compare intervention group to control to see if patients from intervention group obtain benefit in terms of opioid consumption, analgesia and early mobilization.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eric Albrecht

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)