Erector Spinae Plane Block and Postoperative Recovery After Open-Heart Surgery (ESPB-SYSHEART)

November 21, 2025 updated by: Ali AKDOĞAN, Karadeniz Technical University

Effects of Erector Spinae Plane Block on Postoperative Systemic Functions in Patients Undergoing Open-Heart Surgery Via Sternotomy

This prospective randomized controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median sternotomy. Sixty-six participants were randomized to receive either bilateral ultrasound-guided ESPB before anesthesia induction or standard intravenous opioid analgesia. Postoperative outcomes-including pain scores, rescue analgesic requirements, hemodynamic parameters, respiratory variables, and laboratory values-were monitored for forty-eight hours. The study was conducted to determine whether ESPB provides improved postoperative pain control and supports systemic recovery compared with intravenous opioid-based analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open-heart surgery performed through median sternotomy is associated with significant postoperative pain, sympathetic activation, respiratory impairment, and delayed recovery. Conventional postoperative analgesia, primarily based on intravenous opioids, may provide adequate pain relief but is frequently limited by adverse effects such as sedation, nausea, respiratory depression, and hemodynamic fluctuations. Therefore, safer and more effective multimodal analgesia strategies are required for cardiac surgical patients.

The erector spinae plane block (ESPB) is a paraspinal interfascial block that allows the spread of local anesthetic to the dorsal and ventral rami, intercostal nerves, and paravertebral region, providing both somatic and visceral analgesia. ESPB has been increasingly used as an alternative to thoracic epidural analgesia, especially in patients undergoing cardiac surgery where neuraxial techniques may pose risks related to anticoagulation and sympathetic blockade.

This prospective randomized controlled clinical trial was designed to evaluate whether bilateral ultrasound-guided ESPB can improve postoperative systemic functions in patients undergoing elective open-heart surgery via sternotomy. A total of sixty-six adults classified as ASA II-III were randomized into two groups. The intervention group received bilateral ESPB at the T5 level using twenty milliliters of 0.25% bupivacaine per side prior to induction of general anesthesia, whereas the control group received standard intravenous opioid-based analgesia.

Postoperative outcomes were monitored for forty-eight hours and included pain scores measured by the Numeric Rating Scale (NRS), time to rescue analgesia, total analgesic consumption, hemodynamic parameters, respiratory measurements, and laboratory markers such as hemoglobin, creatinine, AST, and ALT. The primary objective was to determine whether ESPB provides superior postoperative pain control compared with intravenous opioid analgesia. Secondary objectives included assessing the effects of ESPB on hemodynamic stability, respiratory recovery, and systemic laboratory parameters.

The study was conducted after ethics committee approval, and written informed consent was obtained from all participants prior to enrollment.

Study Type

Interventional

Enrollment (Actual)

66

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)
    • Trabzon
      • Trabzon, Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Technical University Faculty of Medicine, Farabi Hospital

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

Yes

Description

Inclusion Criteria:

  • Adults aged 18 to 75 years
  • Scheduled for elective open-heart surgery via median sternotomy (CABG or valve surgery)
  • ASA physical status II-III
  • Provided written informed consent
  • BMI < 35 kg/m²

Exclusion Criteria:

  • Age <18 or >75 years
  • Known coagulopathy or anticoagulation contraindicating regional block
  • Infection or dermatological lesion at the injection site
  • Allergy to local anesthetics
  • Chronic use of opioids, anticonvulsants, antidepressants, or corticosteroids
  • Significant psychiatric or cognitive disorder preventing cooperation
  • Severe arrhythmia or hemodynamic instability prior to surgery
  • Local anesthetic toxicity risk factors or anatomic deformity preventing block placement
  • Non-elective or emergency cardiac 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector Spinae Plane Block (ESPB)
Patients received bilateral ultrasound-guided erector spinae plane block at the T5 level before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine was injected on each side.
Procedure: Erector spinae plane block (ESPB)

Bilateral ultrasound-guided erector spinae plane block performed at the T5 vertebral level before induction of general anesthesia.

A total of 20 mL of 0.25% bupivacaine was injected between the erector spinae muscle and the transverse process on each side using a high-frequency linear ultrasound probe and a 22-gauge needle.
Active Comparator: Intravenous Opioid Analgesia (Control)

Standard intravenous opioid-based analgesia administered without regional block.

A fentanyl infusion (0.5 μg/kg/h) was initiated immediately after induction of general anesthesia and continued intraoperatively per institutional protocol.
Drug: Intravenous Opioid Analgesia
Standard intravenous opioid-based analgesia administered without regional block. Fentanyl infusion (0.5 μg/kg/h) was started after induction and continued intraoperatively according to institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity (NRS Score)
Time Frame: First 12 hours after extubation (measured at 1, 6, and 12 hours)
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at standardized postoperative time points.
First 12 hours after extubation (measured at 1, 6, and 12 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Rescue Analgesic Requirement
Time Frame: Within 48 hours post-extubation
Time in hours from extubation to first administration of rescue analgesia (tramadol or diclofenac).
Within 48 hours post-extubation
Total Rescue Analgesic Consumption
Time Frame: 48 hours post-extrubation
Total amount of rescue analgesics administered (mg of tramadol and diclofenac) during the first 48 postoperative hours.
48 hours post-extrubation
Heart Rate (beats per minute)
Time Frame: First 24 postoperative hours
Heart rate (HR) values recorded at predefined postoperative intervals.
First 24 postoperative hours
Mobilization Time
Time Frame: Up to postoperative day 3
Time from ICU admission to first successful mobilization (sitting or standing with assistance).
Up to postoperative day 3
Length of Hospital Stay
Time Frame: From completion of surgery until hospital discharge, up to 14 days.
Total duration of postoperative hospitalization, measured in days.
From completion of surgery until hospital discharge, up to 14 days.
Postoperative Hemoglobin Change
Time Frame: 24 hours after surgery
Difference between preoperative and postoperative hemoglobin levels (g/dL).
24 hours after surgery
Serum Creatinine Level (mg/dL)
Time Frame: Preoperative baseline and postoperative 24 hours (up to 24 hours after surgery).
Serum creatinine concentration will be measured as an indicator of postoperative renal function. Values are reported in milligrams per deciliter (mg/dL). Higher values indicate worse renal function.
Preoperative baseline and postoperative 24 hours (up to 24 hours after surgery).
Mean Arterial Pressure (mmHg)
Time Frame: First 24 postoperative hours
Mean arterial pressure (MAP) values recorded at predefined postoperative intervals.
First 24 postoperative hours
Urine Output (mL/kg/hour)
Time Frame: First 24 hours after surgery (up to 24 hours postoperative).
Urine output will be measured as an indicator of renal perfusion and early postoperative renal function. Values are reported in milliliters per kilogram per hour (mL/kg/h). Higher values indicate better renal function.
First 24 hours after surgery (up to 24 hours postoperative).

Collaborators and Investigators

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

Sponsor

Karadeniz Technical 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)

January 30, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

August 20, 2024

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTU-ESPB-2022-247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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