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Completed

NCT Number: NCT06239025

Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery

The goal of this randomized double blind study is to evaluate the analgesic efficacy of Transversus Thoracis Muscle Plane Block in patients undergoing cardiac surgery with median sternotomy.

one group of participants will receive multimodal analgesia plus ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 0.5 % after induction of general anesthesia, the other group will receive multimodal analgesia without a bloc.

The investigators want to know if participants who receive the Transversus Thoracis Muscle Plane Block with ropivacaine have less pain than participants who do not receive a block.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital du Valais

Sion, 1950, Switzerland

About this study

Participants who undergo elective cardiac surgery with median sternotomy are eligible. They will receive general anaesthesia with multimodal analgesia as is standard in our institution. For study purposes participants will be randomized in a double blinded fashion to receive a Transversus Thoracis Muscle Plane Block with 30 mL of ropivacaine 0.5 %, or no block. As the block is carried out after induction of general anesthesia the participants will not know to which group they are assigned.

all blocks will be carried out after induction of general anesthesia, under full sterile precautions, and with ultrasound guidance. multimodal analgesia intra- and postoperatively is standardized and consists of: sufentanil, ketamine, dexmedetomidine, dexamethasone, paracetamol, metamizole, IV morphine in ICU.

The investigators aim for fast track surgery, i.e. extubation either in the operating room or in ICU within the first 6 postoperative hours.

the primary outcome is postoperative opioid consumption over the first 24 h postoperatively, secondary outcomes are pain scores and opioid-related side effects. all outcomes will be assessed by blinded investigators.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Informed consent
  • Major adult (≥ 18 years old)
  • Body weight ≥ 50 kg. 50 kg is the minimal weight to ensure that participants will not receive an overdose of local anesthetic (ropivacaine 3 mg/kg)
  • Primary cardiac surgery via a sternotomy approach
  • Planned for fast-track procedure (i.e. postoperative extubation time of maximum six hours)

Exclusion criteria

  • • Participation in another study within the 30 days preceding and during the present study
  • Refusal and/or inability to understand or sign the informed consent
  • Emergency cardiac surgery
  • Previous cardiac surgery
  • Hypersensitivity or allergy to ropivacaine and other amide-class LA
  • History of chronic pain
  • History of substance abuse
  • Severe cardiac dysfunction (i.e. LVEF ≤ 35%)
  • Severe obesity (BMI > 40kg/m2)

Treatment and study plan

ultrasound-guided Transversus Thoracis Muscle Plane Block

Other

block with ropivacaine 0.5 %, 30 mL

Primary outcomes

  1. opioid consumption

    Time frame: 24 hours postoperatively

    cumulative intravenous morphine-equivalents

Secondary outcomes

  1. Postoperative pain 2 h

    Time frame: 2 hours postoperatively

    Numeric Rating Scale 0-10

  2. Postoperative pain 6

    Time frame: 6 hours postoperatively

    Numeric Rating Scale 0-10

  3. Postoperative pain 12

    Time frame: 12 hours postoperatively

    Numeric Rating Scale 0-10

  4. Postoperative pain 24

    Time frame: 24 hours postoperatively

    Numeric Rating Scale 0-10

  5. ICU length of stay

    Time frame: 5 days

    ICU length of stay

Sponsors and collaborators

Lead sponsor

Hôpital du Valais

Other

Registry information

Official study title

Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery. A Randomized Controlled Trial

Acronym: TTMP_Block

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2024
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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