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| ID | Type | Description | Link |
|---|---|---|---|
| 5553 | Other Identifier | COMITATO ETICO TERRITORIALE LOMBARDIA 3 |
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Optimization of postoperative analgesia and reduction of opioid consumption are key components of Enhanced Recovery After Surgery (ERAS) protocols in cardiac surgery. Although intravenous opioids have traditionally been the mainstay of analgesic management due to their potent analgesic effect and hemodynamic stability, high-dose opioid use has been associated with respiratory depression, prolonged mechanical ventilation, delayed extubation, longer intensive care unit stay, and multiple short- and long-term adverse effects.
Thoracic wall loco-regional anesthesia techniques represent promising opioid-sparing strategies in minimally invasive cardiac surgery performed via mini-thoracotomy.
The purpose of this prospective randomized study is to compare two loco-regional analgesic techniques - the Erector Spinae Plane (ESP) block and the Serratus Anterior Plane (SAP) block - in adult patients undergoing minimally invasive cardiac surgery.
The study aims to determine whether one technique is superior in reducing postoperative morphine consumption, improving pain control, and enhancing patient-reported quality of recovery as measured by the Italian Quality of Recovery (iQoR) questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serratus Plane Anterior Block (SAP) | Active Comparator | Participants receive an ultrasound-guided Serratus Anterior Plane (SAP) block prior to cardiac surgery performed via a minithoracotomy approach. |
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| Erector Spinae Plane block (ESP) | Active Comparator | Participants receive an ultrasound-guided Erector Spinae Plane (ESP) block prior to cardiac surgery performed via a minithoracotomy approach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus anterior plane block (SAP) | Procedure | The Serratus Anterior Plane (SAP) block is an ultrasound-guided loco-regional analgesic technique performed with the patient in the supine or lateral position. A Stimuplex Ultra 360 needle (22G × 80 mm) is advanced under ultrasound guidance using a 5-10 MHz linear probe to deposit local anesthetic in the fascial plane superficial or deep to the serratus anterior muscle. The block is administered prior to cardiac surgery performed via a minithoracotomy approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective quality of the postoperative period | The primary outcome was patient-reported quality of postoperative recovery, assessed using the Quality of Recovery-15 (QoR-15) questionnaire, Italian version (iQoR-15), on postoperative days 1 and 2. The QoR-15 is a validated 15-item instrument measuring five domains: pain, physical comfort, independence, emotional state, and psychological support. Scores range from 0 (poor recovery) to 150 (excellent recovery), with higher scores indicating better recovery. The questionnaire has strong psychometric properties, including validity, reliability, and responsiveness, and provides a comprehensive evaluation of recovery beyond complications, helping predict adverse outcomes and prolonged hospital stay. | From the Day of Surgery for the Following 48 Hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of pain contrrol | Pain control was assessed using the Numerical Rating Scale (NRS, 0-10) both at rest and during dynamic conditions (coughing, movement, etc.) every 3 hours from patient awakening for the first 12 hours, and then every 12 hours on postoperative days 1 and 2. Higher scores indicate more pain. During the observation period, total opioid consumption was recorded: intraoperative sufentanil (mcg/kg), total morphine consumption (mg), and morphine consumption before and after the second block. The study also evaluated postoperative recovery outcomes, including awakening time, length of stay in the intensive care unit and hospital, as well as the incidence of complications related to analgesia administration, such as nausea, pneumothorax, hemorrhage, local anesthetic systemic toxicity (LAST), and neurological damage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trial Office | Legnano | Italy | 20025 | Italy |
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| Erector Spinae Plane block (ESP) | Procedure | The Erector Spinae Plane (ESP) block is an ultrasound-guided loco-regional analgesic technique performed with the patient in the sitting or lateral position. A Stimuplex Ultra 360 needle (22G × 80 mm) is advanced under ultrasound guidance using a 5-10 MHz linear probe to deposit local anesthetic in the fascial plane deep to the erector spinae muscle at the appropriate thoracic level. The block is administered prior to cardiac surgery performed via a minithoracotomy approach. |
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| From the Day of Surgery for the Following 48 Hours. |