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 (SAPESP)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Procedure: Serratus anterior plane block (SAP); Procedure: Erector Spinae Plane block (ESP)

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Legnano, Italy, Italy, 20025
      • Trial Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Serratus Plane Anterior Block (SAP); Participants receive an ultrasound-guided Serratus Anterior Plane (SAP) block prior to cardiac surgery performed via a minithoracotomy approach.	Procedure: Serratus 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.
Active Comparator: Erector Spinae Plane block (ESP); Participants receive an ultrasound-guided Erector Spinae Plane (ESP) block prior to cardiac surgery performed via a minithoracotomy approach.	Procedure: Erector 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	From the Day of Surgery for the Following 48 Hours.

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anesthesia and Analgesia; Analgesia
• Other Study ID Numbers: 16-2024; 5553 (Other Identifier: COMITATO ETICO TERRITORIALE LOMBARDIA 3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No