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NCT Number: NCT07420712

Serratus Posterior Superior Plane Block in Minimally Invasive Cardiac Surgery

This prospective randomized controlled trial aimed to evaluate the efficacy of serratus posterior superior intercostal plane block (SPSIPB) as a component of a multimodal analgesia strategy for postoperative pain control, opioid consumption, and hemodynamic response in patients undergoing mini-thoracotomy cardiac surgery. The study was planned to include a total of 60 patients, with 30 patients in each group. Patients with ASA physical status I-III scheduled for elective mini-thoracotomy cardiac surgery (coronary artery bypass grafting, valve replacement, atrial septal defect closure, or beating-heart bypass) will be randomized to the SPSIPB group or a control group receiving standard analgesic management without any regional block. The primary outcome is the resting Numeric Rating Scale (NRS) pain score at 1 hour postoperatively. Secondary outcomes include resting and movement (passive shoulder flexion) NRS pain scores at 1, 4, 8, 16, and 24 hours, cumulative 24-hour tramadol consumption, proportion of patients requiring rescue analgesia, intraoperative remifentanil consumption, systolic blood pressure change at incision, incidence of postoperative nausea and vomiting (PONV), patient satisfaction (5-point Likert scale), time to extubation, and intensive care unit length of stay.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kosuyolu High Specialization Training and Research Hospital

Istanbul, 34870, Turkey (Türkiye)

About this study

Introduction

Pain in cardiac surgery is of moderate to severe intensity due to factors such as sternotomy, sternal retraction, harvesting of the internal mammary artery, thoracotomy or thoracoscopy in minimally invasive approaches, and chest tube placement. Minimally invasive cardiac surgery (MICS) aims to shorten hospital length of stay and provide optimal postoperative analgesia in order to facilitate early mobilization and recovery. Adequate pain management reduces pain-related systemic and pulmonary complications. Tachycardia and hypertension secondary to pain increase myocardial oxygen consumption and predispose patients to hemodynamic instability.

Enhanced Recovery After Surgery (ERAS) protocols following cardiac surgery aim to reduce opioid consumption and eliminate opioid-related adverse effects. With increasing awareness of opioid overuse, tolerance, and opioid-induced hyperalgesia, opioid-sparing analgesic strategies have been increasingly adopted. The most important component of opioid-sparing analgesia is the use of regional anesthesia techniques. The Procedure-Specific Postoperative Pain Management (PROSPECT) guidelines recommend plane blocks as part of analgesic management in thoracic surgery. The incidence of severe chronic pain after sternotomy has been reported to be approximately 35% within the first postoperative year. Various regional anesthesia techniques, including thoracic epidural, thoracic paravertebral block, and parasternal intercostal block, have been used for postoperative analgesia in cardiac surgery. However, coagulation abnormalities limit the use of central neuraxial blocks. Consequently, ultrasound-guided fascial plane blocks have gained widespread use in cardiac surgery. Commonly used techniques include the erector spinae plane block, serratus anterior plane block, parasternal block, paravertebral block, pectoral nerve blocks (PECS I-II), and serratus posterior superior intercostal plane block (SPSIPB).

The ultrasound-guided SPSIPB was first described in 2023 by Tulgar et al. through cadaveric studies and a case series involving five patients. Due to its extensive local anesthetic spread and broad sensory dermatomal coverage (C3-T7), it has increasingly been used in cervical and thoracic surgical procedures.

The aim of this study is to evaluate the effectiveness of the serratus posterior superior intercostal plane block (SPSIPB) in postoperative analgesic management for minimally invasive cardiac surgery.

Materials and Methods

This prospective randomized controlled study is planned to be conducted between February 2026 and September 2026 at Kartal Koşuyolu High Specialization Training and Research Hospital. A total of 60 patients (30 in each group) will be included. Inclusion criteria are age ≥18 years, ASA physical status I-III, and scheduled for elective mini-thoracotomy cardiac surgery (coronary artery bypass grafting, valve replacement, atrial septal defect closure, or beating-heart bypass). Exclusion criteria are emergency surgery, renal impairment (eGFR <30 mL/min), hepatic disease (Child-Pugh >B), allergy to local anesthetics or study medications, infection at the injection site, coagulopathy (INR >1.25, aPTT >35 seconds, or platelet count <100,000/µL), body mass index >35 kg/m², body weight <42 kg, pregnancy, history of trauma within the past 24 hours, and neurological or psychiatric disorders affecting consciousness or decision-making capacity.

Eligible patients will be randomized into two equal groups (n=30 each) using sealed opaque envelopes: the SPSIPB group and the control group. All patients will be informed about the study, and written informed consent will be obtained after providing detailed information regarding the plane block procedure. In the preoperative holding area, patients will be monitored, intravenous access will be established with a 20-gauge cannula, and premedication will be administered with intravenous midazolam (0.03 mg/kg) and fentanyl (1 µg/kg). All blocks will be performed under full aseptic conditions while patients receive supplemental oxygen via face mask.

No plane block will be performed in the control group. In the SPSIPB group, patients will be positioned laterally with the surgical side up and the upper extremity extended above the head. Under ultrasound guidance, the scapular spine will be identified using a high-frequency linear probe. The third rib will be visualized medial to the scapula at the level corresponding to the third intercostal space. After identifying the ribs, pleura, and overlying serratus posterior superior muscle, the needle will be advanced until contacting the third rib. Following hydrodissection with 5 mL isotonic saline, 30 mL of 0.25% bupivacaine will be injected between the serratus posterior superior muscle and the third rib. Cranio-caudal spread of the local anesthetic will be confirmed by ultrasound.

Standard intraoperative monitoring will include electrocardiography, peripheral oxygen saturation, invasive arterial blood pressure, near-infrared spectroscopy (NIRS), and bispectral index (BIS). Anesthesia induction will be performed with propofol (1-2 mg/kg) and rocuronium (1 mg/kg). Patients will be intubated with a double-lumen endotracheal tube, and correct placement will be confirmed by bronchoscopy. Anesthesia maintenance will consist of sevoflurane (MAC 0.8-1.0) in a 50% oxygen/air mixture and remifentanil infusion (0.05-0.2 µg/kg/min), targeting a BIS value between 40 and 60. If heart rate or arterial blood pressure increases by more than 20% from baseline, the remifentanil infusion will be increased up to 0.1-2 µg/kg/min. Lung-protective ventilation strategies will be applied during one-lung ventilation.

Hemodynamic parameters, intraoperative remifentanil consumption, and duration of surgery will be recorded. Time to extubation will be documented. Postoperatively, patient-controlled analgesia (PCA) with tramadol will be initiated in cooperative patients. The PCA device will be programmed with tramadol at a concentration of 4 mg/mL, a bolus dose of 2 mL, a lockout interval of 15 minutes, and a 4-hour limit of 100 mg.

Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at postoperative 1, 4, 8, 16, and 24 hours, both at rest and during movement (passive shoulder flexion). Time to first rescue analgesic, incidence of postoperative nausea and vomiting (PONV), and other adverse effects will be recorded. Patients with NRS ≥4 despite PCA will receive intravenous diclofenac 75 mg as rescue analgesia. Lengths of intensive care unit and hospital stay will also be recorded.

Primary outcome: Resting NRS pain score at 1 hour postoperatively

Secondary outcomes: Resting and movement NRS pain scores at 1, 4, 8, 16, and 24 hours, Cumulative 24-hour tramadol consumption ,Proportion of patients requiring rescue analgesia, Intraoperative remifentanil consumption, Systolic blood pressure change at incision, Incidence of postoperative nausea and vomiting (PONV), Patient satisfaction (5-point Likert scale), Time to extubation, Intensive care unit length of stay.

Sample Size and Statistical Analysis

Sample size calculation was performed using G*Power version 3.1.9.2. Based on data from a similar previous study on plane blocks, postoperative 24-hour total opioid consumption was used as the basis. With a significance level of 0.05 and a power of 85%, a minimum of 26 patients per group was required. Considering a potential 20% dropout rate, 30 patients per group (total n=60) will be included.

Statistical analyses will be performed using SPSS version 27.0. Continuous variables will be expressed as mean ± standard deviation or median (minimum-maximum), while categorical variables will be presented as frequencies and percentages. Normality will be assessed using the Shapiro-Wilk test and box plots. Student's t-test or Mann-Whitney U test will be used for intergroup comparisons as appropriate. Categorical variables will be analyzed using the chi-square test or Fisher's exact test. A p value <0.05 will be considered statistically significant.

No additional budget beyond routine clinical care will be required, and no study-specific extra parameters will be collected.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I - III
  • Scheduled for elective minimally invasive coronary artery bypass surgery
  • Ability to understand the study procedures and provide written informed consent

Exclusion criteria

  • Age under 18 years
  • ASA physical status other than I - III
  • Pregnancy
  • Emergency surgery
  • History of trauma within the previous 24 hours
  • Neurological disorders affecting consciousness or decision-making capacity
  • Psychiatric disorders affecting decision-making capacity or cooperation
  • Known allergy to local anesthetic agents
  • Infection or skin disease at the block injection site
  • Body mass index greater than 35 kg/m²
  • Body weight less than 42 kg
  • Coagulation disorders (international normalized ratio >1.25, activated partial thromboplastin time >35 seconds, or platelet count <100,000/µL)

Treatment and study plan

Serratus Posterior Superior Intercostal Plane Block

Procedure

The serratus posterior superior intercostal plane block is performed under ultrasound guidance before surgery, with the patient in the lateral position. After identification of the third rib and the serratus posterior superior muscle, a local anesthetic solution is injected between the muscle and the rib to provide thoracic wall analgesia as part of a multimodal pain management strategy.

Bupivacaine

Drug

Bupivacaine was administered as the local anesthetic for the block.

Ultrasound

Device

Ultrasound guidance was used for block placement.

Primary outcomes

  1. Resting NRS pain score at 1 hour postoperatively

    Time frame: At 1, 6, 12, 18, and 24 hours after surgery (within the first 24 postoperative hours).

    "Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at postoperative 1, 4, 8, 16, and 24 hours, both at rest and during movement (passive shoulder flexion)."

Secondary outcomes

  1. Intraoperative Opioid Consumption

    Time frame: During surgery

    Total remifentanil consumption recorded throughout the intraoperative period.

  2. Time to First Rescue Analgesia

    Time frame: From the end of surgery to the administration of the first rescue analgesic, assessed within the first 24 postoperative hours

    Time elapsed from the end of surgery to the first administration of rescue analgesic medication.

  3. Time to Extubation

    Time frame: From completion of surgery to successful tracheal extubation, assessed during the intraoperative and immediate postoperative period.

    Duration from completion of surgery to successful tracheal extubation.

  4. Length of Stay in the Intensive Care Unit (ICU)

    Time frame: From admission to the intensive care unit until ICU discharge, assessed up to 30 days postoperatively.

    Total duration of stay in the intensive care unit measured in hours.

  5. Postoperative Opioid Consumption

    Time frame: 24 hours after surgery

    Total Tramadol consumption recorded throughout the postoperative period.

  6. Postoperative Resting Pain Scores

    Time frame: 4, 8, 16, and 24 hours after surgery

    Pain intensity assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at rest

  7. Postoperative Movement Pain Scores

    Time frame: 1, 4, 8, 16, and 24 hours after surgery

    Pain intensity assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) during movement (passive shoulder flexion)

  8. Hemodynamic Stability (Systolic Blood Pressure Change at Incision)

    Time frame: At the time of surgical incision

    Change in systolic blood pressure from baseline to surgical incision

  9. Postoperative Nausea and Vomiting (PONV)

    Time frame: 24 hours after surgery

    Incidence of postoperative nausea and vomiting assessed using a 0-3 scale

  10. Patient Satisfaction

    Time frame: 24 hours after surgery

    Patient satisfaction score assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied)

Sponsors and collaborators

Lead sponsor

Kartal Kosuyolu High Speciality Training and Research Hospital

Other Gov

Registry information

Official study title

Multimodal Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Study on the Effectiveness of the Serratus Posterior Superior Intercostal Plane Block

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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