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NCT Number: NCT07259057

Erector Spinae Plane Block and Postoperative Recovery After Open-Heart Surgery

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University Faculty of Medicine, Farabi Hospital

Trabzon, 61080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Erector spinae plane block (ESPB)

Procedure

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.

Intravenous Opioid Analgesia

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. Heart Rate (beats per minute)

    Time frame: First 24 postoperative hours

    Heart rate (HR) values recorded at predefined postoperative intervals.

  4. Mobilization Time

    Time frame: Up to postoperative day 3

    Time from ICU admission to first successful mobilization (sitting or standing with assistance).

  5. 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.

  6. Postoperative Hemoglobin Change

    Time frame: 24 hours after surgery

    Difference between preoperative and postoperative hemoglobin levels (g/dL).

  7. 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.

  8. Mean Arterial Pressure (mmHg)

    Time frame: First 24 postoperative hours

    Mean arterial pressure (MAP) values recorded at predefined postoperative intervals.

  9. 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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Acronym: ESPB-SYSHEART

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

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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