Clinical Trials Directory

Trials / Completed

CompletedNCT07433114

Erector Spinae Plane Block (ESP) vs Serratus Anterior Plane Block (SAP) for Loco-Regional Analgesia in Adult Patients Undergoing Minimally Invasive Cardiac Surgery Via Mini-Thoracotomy: Impact on Morphine Consumption, Pain Control, and Quality of Recovery

Studio Randomizzato Prospettico Comparativo di 2 Tecniche di Analgesia Loco-regionale Per Interventi di Cardiochirurgia Con Approccio Mini-toracotomico

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
57 (actual)
Sponsor
Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2025-03-05
Primary completion
2025-05-31
Completion
2025-10-30
First posted
2026-02-25
Last updated
2026-02-27

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07433114. Inclusion in this directory is not an endorsement.