Comparison of Erector Spinae Plane Block (ESPB) With the Combination of Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) in the Management of Postoperative Sternotomy Pain in Patients Undergoing Cardiac Surgery Via Sternotomy

March 13, 2026 updated by: Onur Alp, Uludag University

Sternotomi İle Kardiyak Cerrahi Planlanan Hastalarda Postoperatif Sternotomi Ağrısının Yönetiminde Erektör Spina Plan Blok (ESPB) Ile Yüzeyel Parasternal İnterkostal Plan Bloğu (SPIPB) ve Serratus Anterior Plan Bloğu (SAPB) Kombinasyonunun Karşılaştırılması

This study aims to compare the effectiveness of two regional anesthesia techniques in managing pain for participants undergoing cardiac surgery via sternotomy. The investigators will evaluate whether the Erector Spinae Plane Block (ESPB) or a combination of the Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) provides better pain control and recovery outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators aim to compare the effects of the erector spinae plane block (ESPB) versus the combination of superficial parasternal intercostal plane block (SPIPB) and serratus anterior plane block (SAPB) in the management of postoperative sternotomy pain among participants scheduled for cardiac surgery via sternotomy.

Study design and methods: A total of 50 participants (aged 18-80, ASA I-III) scheduled for sternotomy will be randomly assigned to one of two groups:

ESPB Group: Participants receive the Erector Spinae Plane Block. SPIPB + SAPB Group: Participants receive a combination of both blocks. Prior to the induction of general anesthesia, participants are randomized into two groups: the ESPB group and the SPIPB + SAPB group. Nerve blocks are performed in both groups. Visual Analog Scale (VAS) scores at rest and during coughing, intraoperative opioid consumption, postoperative behavioral pain scores, extubation times, and time to the first rescue analgesic requirement are evaluated.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Nilüfer
      • Bursa, Nilüfer, Turkey (Türkiye), 16235
        • Recruiting
        • Bursa Uludag University Hospital
        • Principal Investigator:
          • Elif Basagan Mogol, Professor of Anesthesiology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged between 18 and 80 years.
  • Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
  • Patients scheduled for elective cardiac surgery via median sternotomy.
  • Patients who have provided written informed consent.

Exclusion Criteria:

  • Pregnancy or suspected pregnancy.
  • Body Mass Index (BMI) > 35 kg/m².
  • Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine).
  • Suspected coagulopathy or bleeding disorders.
  • Infection at the site of the regional block injection.
  • Severe hepatic or renal failure.
  • Severe neurological or psychiatric disorders.
  • Emergency surgical procedures.
  • Re-operation cases (Redo-surgery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector Spinae Plane Block Group
Participants in this group will receive a bilateral ultrasound-guided Erector Spinae Plane Block (ESPB) for postoperative analgesia.
Procedure: Erector spinae plane block (ESPB)
Bilateral ultrasound-guided ESPB is performed at the T4 or T5 vertebral level. Following skin preparation and visualization of the transverse process and erector spinae muscle, a block needle is inserted. After confirming the needle tip position between the muscle and the transverse process, 0.5 mL/kg of 0.25% Bupivacaine is injected on each side.
Active Comparator: SPIPB and SAPB Group
Participants in this group will receive a combination of bilateral ultrasound-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) for postoperative analgesia.
Procedure: Superficial Parasternal Intercostal Plane Block (SPIPB)
Bilateral ultrasound-guided SPIPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for sternotomy.
Procedure: Serratus Anterior Plane Block (SAPB)
Bilateral ultrasound-guided SAPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for the chest wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (Visual Analog Scale Score)
Time Frame: At 0, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively.
Pain levels assessed using the Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).
At 0, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation Time
Time Frame: From the end of surgery until the date of successful endotracheal tube removal, assessed up to 24 hours.
The duration from the end of the surgical procedure until the patient is successfully extubated.
From the end of surgery until the date of successful endotracheal tube removal, assessed up to 24 hours.
Total Postoperative Opioid Consumption
Time Frame: From the end of surgery up to 24 hours postoperatively.
Total amount of opioid (e.g., morphine or fentanyl) administered to the patient in the first 24 hours.
From the end of surgery up to 24 hours postoperatively.
Behavioral Pain Scale (BPS)
Time Frame: From ICU admission until extubation, assessed up to 24 hours.
Pain assessment based on facial expression, upper limb movement, and compliance with ventilation.
From ICU admission until extubation, assessed up to 24 hours.
Time to First Rescue Analgesic
Time Frame: From the end of surgery until the first dose of rescue analgesic, assessed up to 24 hours.
The time elapsed from the end of surgery until the patient first requires additional pain medication.
From the end of surgery until the first dose of rescue analgesic, assessed up to 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-AKD-251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to share individual participant data to protect patient privacy and comply with institutional data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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