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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Patients will benefit of our institutional intensive-care unit analgesia protocol |
|
| Intervention group | Experimental | Patients will benefit of a transversus thoracic muscle plane block and our institutional intensive-care unit analgesia protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transversus thoracic muscle plane block | Drug | Ultrasound guided bilateral parasternal injection of bupivacain 0.375%, 20ml, at 4th thoracic vertebral level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount (in mg) of opioid consumption within the first 24 hours | Total opioid consumption | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Rancati, Attending physician | Contact | 0041 79 556 88 68 | valentina.rancati@chuv.ch | |
| Eric Albrecht, Attending physician | Contact | 0041 21 314 20 07 | eric.albrecht@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Rancati, Attending physician | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUVaudois | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Standard postoperative analgesia | Procedure | Standard of postoperative ICU analgesic care, per institutional protocol |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |