ClinicalTrials.gg
Status unknownNCT05681507Updated Jan 23, 2023

Efficacy of TTMPB in Adult Cardiac Surgery

An interventional study of Transversus thoracic muscle plane block and Standard postoperative analgesia in Acute Post Operative Pain, sponsored by Eric Albrecht. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Eric Albrecht · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 100 Years
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.

Planned enrollment
13th of 47
140 · median 100
Started
2022
with 1 other
No phase
29 of 56
9 open now
Registered
42nd of 56
by date
Lead sponsor
3 of 56
Eric Albrecht

Among the 56 studies in Pain, Postoperative with a site in Switzerland, this one is the 13th largest by planned enrollment of the 47 interventional ones, is one of 2 that started in 2022, is one of 29 with no phase, and was the 42nd registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

No phasethis study29 · 9 open
Phase 411 · 0 open
Observational9 · 3 open
Phase 34 · 0 open
Phase 22 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2004; this study’s year is marked. 2 started in 2022.

Size and results

Median enrollment 100 across the 47 interventional studies, 355 across the 9 observational. Of the 42 that completed or were terminated, 4 (10%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 56 studies in Pain, Postoperative with a site in Switzerland, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Acute Post Operative Pain

Browse trials for

Keywords

  • Transversus Thoracic Muscle Plane Block
  • Adult Cardiac Surgery
  • Sternotomy
04

Who can participate

Ages eligible
18 Years to 100 Years
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

  • Direct 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

Exclusion Criteria:

  • Participation in another study with drug within the 30 days preceding and during the present study
  • Refusal and/or inability to understand or sign the
  • Emergent cardiac surgery
  • Previous cardiac surgery
  • Known 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)
  • concomitant diseases: severe cardiac dysfunction (i.e. ≤ 35%); severe (i.e. FEV \< 50%); severe hepatic disease.
  • Severe obesity ( > 35kg/m2)
Terms in these criteria, in plain language(7)

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • Active comparator
    Control group

    Patients will benefit of our institutional intensive-care unit analgesia protocol

    Procedure: Standard postoperative analgesia

  • 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

Interventions

  • DrugTransversus thoracic muscle plane block

    Ultrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level.

    Also known as: TTMPB

  • ProcedureStandard postoperative analgesia

    Standard of postoperative ICU analgesic care, per institutional protocol

06

What researchers measure

Primary outcomes

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

    Total opioid consumption

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • CHUVaudois
    Lausanne, VD 1011, Switzerland
    Recruiting
08

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

Started Dec 2022 (actual). Primary completion is estimated for Dec 2023, 12 months after the start.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 12 months is close to that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

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

Registered
Dec 13, 2022
First posted
Jan 12, 2023
StartActual
Dec 1, 2022
Primary completionEst.
Dec 31, 2023
CompletionEst.
May 31, 2024
Last update
Jan 23, 2023
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 Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05681507
Lead sponsor
Eric Albrecht
Responsible party
Eric Albrecht (Professor of Clinical Anesthesia, Centre Hospitalier Universitaire Vaudois) — Sponsor-investigator
First posted
Jan 12, 2023
Start date
Dec 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
May 31, 2024 (estimated)
Last update
Jan 23, 2023

Study contacts

Valentina Rancati, Attending physician
Contact
valentina.rancati@chuv.ch
0041 79 556 88 68
Eric Albrecht, Attending physician
Contact
eric.albrecht@chuv.ch
0041 21 314 20 07
Valentina Rancati, Attending physician
principal investigator · Centre Hospitalier Universitaire Vaudois

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 status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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