Efficacy of TTMPB in Adult Cardiac Surgery

Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Post Operative Pain
• Intervention / Treatment: Procedure: Standard postoperative analgesia; Drug: Transversus thoracic muscle plane block

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valentina Rancati, Attending physician; Phone Number: 0041 79 556 88 68; Email: valentina.rancati@chuv.ch
• Study Contact Backup: Name: Eric Albrecht, Attending physician; Phone Number: 0041 21 314 20 07; Email: eric.albrecht@chuv.ch

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Recruiting
      • CHUVaudois
      • Contact: Valentina Rancati, Attending Physician; Phone Number: 0041795568868; Email: valentina.rancati@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients will benefit of our institutional intensive-care unit analgesia protocol	Procedure: Standard postoperative analgesia; Standard of postoperative ICU analgesic care, per institutional protocol
Experimental: Intervention group; Patients will benefit of a transversus thoracic muscle plane block and our institutional intensive-care unit analgesia protocol	Drug: Transversus thoracic muscle plane block; Ultrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level.; Other Names: TTMPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount (in mg) of opioid consumption within the first 24 hours	Total opioid consumption	24 hours

Collaborators and Investigators

• Sponsor: Eric Albrecht
• Investigators: Principal Investigator: Valentina Rancati, Attending physician, Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Adult Cardiac Surgery; Sternotomy; Transversus Thoracic Muscle Plane Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: TTMPB-Heart Trial (2022-01126)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No