About this trial
Background and Purpose: Median sternotomy is the standard surgical approach for cardiac procedures, yet it is associated with significant postoperative pain. Inadequate pain management can lead to pulmonary complications and chronic pain syndromes. While opioids are a cornerstone of multimodal analgesia, their side effects-such as sedation, respiratory depression, and nausea-can delay recovery. Furthermore, neuraxial techniques like epidural analgesia are often avoided in cardiac surgery due to the risks associated with systemic heparinization. This study aims to compare the efficacy of two non-neuraxial regional anesthesia techniques: the combination of Transversus Thoracic Plane Block (TTPB) and Serratus Anterior Plane Block (SAPB) versus the Erector Spinae Plane Block (ESPB).
Study Design and Population: This prospective, randomized study includes 50 patients (ASA I-III, aged 18-80) undergoing elective cardiac surgery via median sternotomy. Patients are randomized into two groups:
TTPB + SAPB Group: Patients receive ultrasound-guided blocks targeting the anterior and lateral chest wall.
ESPB Group: Patients receive ultrasound-guided blocks targeting the paravertebral and intercostal spaces from a posterior approach.
Intervention and Procedures: Following standardized anesthesia induction and invasive monitoring, the respective blocks are performed under ultrasound guidance. Intraoperative hemodynamic data are recorded at key surgical stages (incision, sternotomy, CPB). In the postoperative period in the intensive care unit (ICU), all patients will receive a standardized multimodal analgesia protocol including intravenous (IV) paracetamol and IV tenoxicam. While patients are intubated, pain will be assessed using the Behavioral Pain Scale (BPS). If the BPS score is above 3, IV fentanyl will be administered as rescue analgesia.
Following extubation, pain levels will be evaluated using the Visual Analog Scale (VAS) at rest and during coughing at specific time points (0, 1, 2, 4, 8, 12, 16, and 24 hours). If the post-extubation VAS score is 4 or higher, intramuscular meperidine will be given as rescue analgesia. Additionally, IV ondansetron will be administered in case of nausea or vomiting. The study will also evaluate the time to extubation, time to clinical transport, and patient/surgeon satisfaction using a 5-point Likert scale.
Primary and Secondary Outcomes:
The primary objective of this study is to compare postoperative pain intensity between the study groups using the Visual Analog Scale (VAS) (0-10) and the Behavioral Pain Scale (BPS) (3-12).
Secondary objectives include:
Opioid Consumption: Comparison of total intraoperative and postoperative opioid (IV fentanyl and IM meperidine) consumption within the first 24 hours.
Recovery Milestones: Measurement of time to extubation, time to first mobilization, and time to clinical transport to the surgical ward.
Clinical Satisfaction and Safety: Assessment of patient and surgeon satisfaction using a 5-point Likert scale, and monitoring the incidence of opioid-related side effects, specifically postoperative nausea and vomiting (PONV) requiring ondansetron.
Expected Impact:
By identifying the most effective regional anesthesia technique (TTPB+SAPB vs. ESPB) in conjunction with a standardized multimodal analgesia protocol (IV paracetamol and tenoxicam), this study seeks to maximize postoperative pain control and patient comfort. The results aim to achieve superior analgesia with lower pain scores, thereby facilitating earlier mobilization, reducing the incidence of postoperative complications, and enhancing the overall recovery process for patients undergoing cardiac surgery via median sternotomy. This approach ultimately contributes to the development of more effective, pain-centered recovery protocols in the intensive care unit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 and 80 years.
Patients with American Society of Anesthesiologists (ASA) physical status I, II, or III.
Patients who provide written informed consent.
Patients scheduled for cardiac surgery via elective sternotomy.
Disqualifiers
Pregnancy or suspected pregnancy
Body Mass Index (BMI) > 35 kg/m²
History of allergy to local anesthetics or opioids
Suspected coagulopathy or infection at the injection site
Trial design
Parallel
Treatments tested in this trial
TTP Block
Procedure/SurgeryA combination of Transversus Thoracic Plane Block (TTPB) at the T4-T5 level will be performed using 0.25% bupivacaine (0.5 mg/kg)
ESP Block
Procedure/SurgeryErector Spinae Plane Block (ESPB) at the T4 transverse process level will be performed using 0.25% bupivacaine (0.5 mg/kg)
SAP Block
Procedure/SurgerySerratus Anterior Plane Block (SAPB) at the 5th rib level will be performed using 0.25% bupivacaine (0.5 mg/kg)
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Pain Intensity
Pain will be assessed using the Visual Analog Scale (VAS) (0 = no pain, 10 = worst possible pain) during rest and coughing at the 0th minute, and 1st, 2nd, 4th, 8th, 12th, 16th, and 24th hours post-extubation.
Secondary outcomes
Behavioral Pain Scale (BPS) Scores
Assessment of pain in intubated patients (Score range: 3-12). Higher scores indicate more pain.
Total Rescue Analgesic Consumption
The total amount (mg) of intravenous Fentanyl and intramuscular Meperidine administered as rescue analgesics.
Time to Extubation
The duration from the end of surgery until the patient meets extubation criteria and is extubated.
Time to Transport to Ward
The duration from ICU admission until the patient is stable enough to be transferred to the surgical ward.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.