Efficacy of TTMPB in Adult Cardiac Surgery (NCT05681507) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of TTMPB in Adult Cardiac Surgery
Switzerland140 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total amount (in mg) of opioid consumption within the first 24 hours