ClinicalTrials.gg
CompletedNCT06239025TTMP_BlockUpdated Jun 15, 2025

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

A Phase 4 interventional study of ultrasound-guided Transversus Thoracis Muscle Plane Block in Postoperative Pain, sponsored by Hôpital du Valais. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Hôpital du Valais · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Pain, Postoperative with a site in Switzerland — 12 open to participants now, 12 under way, none of them phase 3. Pain, Postoperative · Switzerland.

Enrollment
19th of 47
100 · median 100
Started
2024
with 3 others
Phase 4
11 of 56
none open now
Registered
50th of 56
by date

Among the 56 studies in Pain, Postoperative with a site in Switzerland, this one is the 19th largest by enrollment of the 47 interventional ones that give a count, is one of 4 that started in 2024, is one of 11 in phase 4, and was the 50th registered.

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

12 of the 56 studies in Pain, Postoperative with a site in Switzerland are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Postoperative Pain

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

      • 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

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
      • Emergency cardiac surgery
      • Previous cardiac surgery
      • or allergy to ropivacaine and other amide-class LA
      • History of chronic pain
      • History of substance abuse
      • Severe cardiac dysfunction (i.e. ≤ 35%)
      • Severe obesity ( > 40kg/m2)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Block + multimodal analgesia

    Multimodal analgesia + TTMP block with ropivacaine 0.5 %, 30 mL

    Other: ultrasound-guided Transversus Thoracis Muscle Plane Block

  • No intervention
    Multimodal Analgesia

    Multimodal Analgesia without a block

Interventions

  • Otherultrasound-guided Transversus Thoracis Muscle Plane Block

    block with ropivacaine 0.5 %, 30 mL

06

What researchers measure

Primary outcomes

  1. opioid consumption

    cumulative intravenous morphine-equivalents

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Postoperative pain 2 h

    Numeric Rating Scale 0-10

    Time frame: 2 hours postoperatively

  2. Postoperative pain 6

    Numeric Rating Scale 0-10

    Time frame: 6 hours postoperatively

  3. Postoperative pain 12

    Numeric Rating Scale 0-10

    Time frame: 12 hours postoperatively

  4. Postoperative pain 24

    Numeric Rating Scale 0-10

    Time frame: 24 hours postoperatively

  5. ICU length of stay

    ICU length of stay

    Time frame: 5 days

07

Study locations

1 site
  • Hopital du Valais
    Sion, 1950, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2024 to primary completion in May 2025, 9 months.

Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 9 months is below that.

Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2024
First posted
Feb 2, 2024
StartActual
Aug 15, 2024
Primary completionActual
May 31, 2025
CompletionActual
Jun 12, 2025
Last update
Jun 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06239025
Lead sponsor
Hôpital du Valais
Responsible party
Sponsor
First posted
Feb 2, 2024
Start date
Aug 15, 2024
Primary completion
May 31, 2025
Completion
Jun 12, 2025
Last update
Jun 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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