Cardiac Surgery
Conditions
Brief summary
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.
Interventions
PROCEDURESerratus anterior plane block (SAP)
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.
PROCEDUREErector Spinae Plane block (ESP)
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.
Sponsors
Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age undergoing cardiac surgery via a mini thoracotomy approach * patient agreement to participate in the protocol and sign the informed consent.
Exclusion criteria
* patients with psychiatric disorders * patients who have already undergone surgery involving the chest wall * patients suffering from chronic pain already undergoing home therapy * allergy to NSAIDs/paracetamol * absence of informed consent * participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the five half-lives of the study drug (whichever is longer) * pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective quality of the postoperative period | From the Day of Surgery for the Following 48 Hours. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of pain contrrol | From the Day of Surgery for the Following 48 Hours. | 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. |
Countries
Italy
Outcome results
None listed