Cardiac SurgerySAPESPNCT07433114
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
A study testing Serratus anterior plane block (SAP) and Erector Spinae Plane block (ESP) in people with Cardiac Surgery, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Serratus anterior plane block (SAP) and Erector Spinae Plane block (ESP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Serratus anterior plane block (SAP), Erector Spinae Plane block (ESP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior plane block (SAP)Procedure or surgery
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.
Erector Spinae Plane block (ESP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Erector Spinae Plane block (ESP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the Day of Surgery for the Following 48 Hours.
Secondary outcomes (1)
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.
Measured: From the Day of Surgery for the Following 48 Hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start5 Mar 2025
- Primary completion31 May 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433114
- Sponsor's protocol ID
- 16-2024
- Other IDs
- 5553
- Acronym
- SAPESP
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Randomizzato Prospettico Comparativo di 2 Tecniche di Analgesia Loco-regionale Per Interventi di Cardiochirurgia Con Approccio Mini-toracotomico
- ClinicalTrials.gov ID
- NCT07433114
- Acronym / sponsor ID
- SAPESP / 16-2024
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di LegnanoUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Plane Anterior Block (SAP) | Active comparator | Procedure: Serratus anterior plane block (SAP)Participants receive an ultrasound-guided Serratus Anterior Plane (SAP) block prior to cardiac surgery performed via a minithoracotomy approach. |
| Erector Spinae Plane block (ESP) | Active comparator | Procedure: Erector Spinae Plane block (ESP)Participants receive an ultrasound-guided Erector Spinae Plane (ESP) block prior to cardiac surgery performed via a minithoracotomy approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Serratus Plane Anterior Block (SAP) |
| 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. | Procedure or surgery | Erector Spinae Plane block (ESP) |
Primary outcome
Subjective quality of the postoperative period
Time frame: 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.
1 secondary outcome
Efficacy of pain contrrol
Time frame: From the Day of Surgery for the Following 48 Hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus anterior plane block (SAP) and Erector Spinae Plane block (ESP) in people with Cardiac Surgery, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective quality of the postoperative period (time frame: From the Day of Surgery for the Following 48 Hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.