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

NCT07433114 | Completed

• 2 other identifiers: 16-20245553
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of pain contrrol

  From the Day of Surgery for the Following 48 Hours.

Study Arms (2)

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.

Procedure: Serratus anterior plane block (SAP)

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.

Procedure: Erector Spinae Plane block (ESP)

Interventions

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.

Serratus Plane Anterior Block (SAP)

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.

Erector Spinae Plane block (ESP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Trial Office

Legnano, Italy, 20025, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 25, 2026
• Study Start: March 5, 2025
• Primary Completion: May 31, 2025
• Study Completion: October 30, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)