Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2022-12-01
2024-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control group
Patients will benefit of our institutional intensive-care unit analgesia protocol
Standard postoperative analgesia
Standard of postoperative ICU analgesic care, per institutional protocol
Intervention group
Patients will benefit of a transversus thoracic muscle plane block and our institutional intensive-care unit analgesia protocol
Transversus thoracic muscle plane block
Ultrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level.
Interventions
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Transversus thoracic muscle plane block
Ultrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level.
Standard postoperative analgesia
Standard of postoperative ICU analgesic care, per institutional protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
100 Years
ALL
No
Sponsors
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Eric Albrecht
OTHER
Responsible Party
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Eric Albrecht
Professor of Clinical Anesthesia
Principal Investigators
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Valentina Rancati, Attending physician
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Vaudois
Locations
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CHUVaudois
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TTMPB-Heart Trial (2022-01126)
Identifier Type: -
Identifier Source: org_study_id
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