Studio Randomizzato Prospettico Comparativo di 2 Tecniche di Analgesia Loco-regionale Per Interventi di Cardiochirurgia Con Approccio Mini-toracotomico
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Subjective quality of the postoperative period
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Serratus Plane Anterior Block (SAP)
The Serratus Anterior Plane (SAP) block is performed with the patient in the supine or lateral position, using a Stimuplex Ultra 360 needle (22G × 80 mm), under ultrasound guidance with a 5-10 MHz linear probe.
Intervention: Analgesia (Procedure)
Erector Spinae Plane (ESP)
The Erector Spinae Plane (ESP) block is performed with the patient in the sitting or lateral position, using a Stimuplex Ultra 360 needle (22G × 80 mm), under ultrasound guidance with a 5-10 MHz linear probe.
Intervention: Analgesia (Procedure)
Outcomes
Primary Outcomes
Subjective quality of the postoperative period
Time Frame: FROM THE DAY OF THE SURGERY FOR THE FOLLOWING 48 HOURS.
The primary outcome was patient-reported quality of postoperative recovery, assessed with the Italian Quality of Recovery questionnaire (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). It 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. The QoR-15 is a shortened version of the QoR-40, takes about 2.5 minutes to complete, and the validated Italian version (iQoR-15) was used for Italian-speaking patients.
Secondary Outcomes
- Efficacy of pain contrrol(FROM THE DAY OF THE SURGERY FOR THE FOLLOWING 48 HOURS.)