Comparison of the Efficacy of Combined Transversus Thoracic Plane Block and Serratus Anterior Plane Block Versus Erector Spinae Plane Block in the Management of Sternotomy Pain

NCT07452627 | Recruiting

• 1 other identifier: 25-AKD-310
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sternotomy; Postoperative Pain; Nerve Block; Patient Outcome Assessment

Keywords

Transversus Thoracic Plane Block; Serratus Anterior Plane Block; Erector Spinae Plane Block; Sternotomy Pain; Cardiac Surgery; Multimodal Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 hours post-extubation.

Secondary Outcomes (6)

• Behavioral Pain Scale (BPS) Scores

  From admission to ICU until extubation (approx. 6-12 hours).

• Total Rescue Analgesic Consumption

  Up to 24 hours post-operation.

• Time to Extubation

  From the end of surgery up to 12 hours.

• Time to Transport to Ward

  Up to 48 hours.

• Patient Satisfaction Score

  At the 24th hour post-operation.

Study Arms (2)

TTPB+ SAPB Group

EXPERIMENTAL

Patients in this group will receive a combination of Transversus Thoracic Plane Block and Serratus Anterior Plane Block for postoperative analgesia.

Procedure: TTP Block; Procedure: SAP Block

ESPB Group

EXPERIMENTAL

Patients in this group will receive Erector Spinae Plane Block for postoperative analgesia.

Procedure: ESP Block

Interventions

TTP Block PROCEDURE

A combination of Transversus Thoracic Plane Block (TTPB) at the T4-T5 level will be performed using 0.25% bupivacaine (0.5 mg/kg)

TTPB+ SAPB Group

ESP Block PROCEDURE

Erector Spinae Plane Block (ESPB) at the T4 transverse process level will be performed using 0.25% bupivacaine (0.5 mg/kg)

ESPB Group

SAP Block PROCEDURE

Serratus Anterior Plane Block (SAPB) at the 5th rib level will be performed using 0.25% bupivacaine (0.5 mg/kg)

TTPB+ SAPB Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Severe neurological, psychiatric, hepatic, or renal failure

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University Hospital

Bursa, Nilüfer, 16235, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.

  PMID: 36581838 BACKGROUND

• Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.

  PMID: 30052229 BACKGROUND

• Mansour MA, Mahmoud HE, Fakhry DM, Kassim DY. Comparison of the effects of transversus thoracic muscle plane block and pecto-intercostal fascial block on postoperative opioid consumption in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2024 Feb 10;24(1):63. doi: 10.1186/s12871-024-02432-w.

  PMID: 38341525 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)