Clincosm LogoSign in Get a demo

Efficacy of TTMPB in Adult Cardiac Surgery

Sponsor
Eric Albrecht (Other)
Overall Status
Recruiting
CT.gov ID
NCT05681507
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Transversus thoracic muscle plane block
  • Procedure: Standard postoperative analgesia
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Transversus Thoracic Muscle Plane Block in Adult Cardiac Surgery: A Randomized Controlled Trial
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total amount (in mg) of opioid consumption within the first 24 hours [24 hours]

      Total opioid consumption

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHUVaudois Lausanne VD Switzerland 1011

    Sponsors and Collaborators

    • Eric Albrecht

    Investigators

    • Principal Investigator: Valentina Rancati, Attending physician, Centre Hospitalier Universitaire Vaudois

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric Albrecht, Professor of Clinical Anesthesia, Centre Hospitalier Universitaire Vaudois
    ClinicalTrials.gov Identifier:
    NCT05681507
    Other Study ID Numbers:
    • TTMPB-Heart Trial (2022-01126)
    First Posted:
    Jan 12, 2023
    Last Update Posted:
    Jan 23, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eric Albrecht, Professor of Clinical Anesthesia, Centre Hospitalier Universitaire Vaudois
    Transversus Thoracic Muscle Plane Block
    Adult Cardiac Surgery
    Sternotomy
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Jan 23, 2023