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NCT Number: NCT07304635

Comparison of the Postoperative Analgesic Effectiveness of Erector Spinae Plane Block Versus Its Combination With Superficial Parasternal Intercostal Plane Block Within the ERACS Program

This prospective, randomized, double-blind, parallel-group clinical trial within the Enhanced Recovery After Cardiac Surgery (ERACS) program compares postoperative analgesic effectiveness of bilateral erector spinae plane (ESP) block versus ESP combined with superficial parasternal intercostal plane (SPIP) block in adult patients undergoing elective cardiac surgery via median sternotomy.

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Key information

Conditions

Sternotomy Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Postoperative Pain Management Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Faculty of Medicine

Ankara, 06230, Turkey (Türkiye)

About this study

Rationale: Effective multimodal, opioid-sparing analgesia is crucial in cardiac surgery to enhance recovery and reduce pulmonary and cognitive complications. Neuraxial techniques (e.g., epidural) carry increased hematoma risk under anticoagulation; hence, fascial plane blocks like ESP and SPIP are safer alternatives.

Methodology: Randomized (ResearchRandomizer.org), 1:1 allocation, opaque sealed envelopes. ESP and SPIP performed under ultrasound guidance at standardized doses and locations.

Blinding: Patients and postoperative evaluators are blinded; block-performing anesthesiologist unblinded but uninvolved in assessment.

Follow-up: 0-72 hours after extubation with predefined time points for VAS, RASS, and Nu-DESC evaluations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for elective cardiac surgery via median sternotomy under the ERACS protocol
  • Age between 18 and 80 years
  • ASA physical status II-III
  • Body Mass Index (BMI) between 18 and 35 kg/m²
  • No cognitive impairment (able to cooperate and follow commands)
  • No history of chronic pain or regular analgesic use
  • Provided written informed consent after detailed explanation of the study

Exclusion criteria

  • Age < 18 years or > 80 years
  • ASA physical status ≥ IV
  • Emergency surgery
  • Pregnant or breastfeeding women
  • Redo coronary artery bypass surgery
  • Pre-existing cognitive disorder or psychiatric illness affecting pain or delirium evaluation
  • Infection or skin lesion at the injection site
  • Known allergy or hypersensitivity to local anesthetics (bupivacaine or amide type)
  • Chronic pain or opioid use prior to surgery
  • Unwillingness to participate or withdrawal of consent at any stage

Treatment and study plan

Procedure: Erector Spinae Plane (ESP) Block

Procedure

A bilateral ultrasound-guided erector spinae plane block will be performed at the T4-T5 vertebral level after induction of general anesthesia.

Using an 80 mm peripheral nerve block needle and an in-plane approach, 30 mL of 0.25% bupivacaine per side will be injected into the fascial plane deep to the erector spinae muscle.

The spread of the local anesthetic will be visualized in real time in a craniocaudal direction.

This technique provides multidermatomal somatic and visceral analgesia (approximately T2-T9).

Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block

Procedure

After induction of general anesthesia, patients will receive:

Bilateral ESP block with 20 mL of 0.25% bupivacaine per side, performed as described above at the T5 level, and

Bilateral SPIP block performed at the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe.

For the SPIP block, after confirming needle placement with hydrodissection (1-3 mL saline) and negative aspiration, 10 mL of 0.25% bupivacaine per side will be injected between the pectoralis major and external intercostal muscles.

Primary outcomes

  1. VAS (resting)

    Time frame: Up to 72 hours post-extubation

    Average of VAS scores at 0, 1, 6, 12, 24, 48, and 72 hours after extubation (t=0). Lower scores indicate better analgesia.

    Pain was assessed using the 0-10 Visual Analog Scale (VAS).

    Pain severity was classified as follows:

    0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Rescue analgesia was administered when VAS score was > 4.

Secondary outcomes

  1. VAS (movement)

    Time frame: 0-72 hours

    Mean VAS scores during movement at all time points

  2. Total rescue tramadol use (mg)

    Time frame: 0-72 hours

    Cumulative IV tramadol dose

  3. Time to first rescue analgesic (min)

    Time frame: 0-72 hours

    Time between extubation and first rescue tramadol

  4. Delirium incidence (Nu-DESC ≥ 2)

    Time frame: 12, 24, 48, 72 hours

    Nursing Delirium Screening Scale (Nu-DESC) score ≥ 2 Delirium was assessed using the Nursing Delirium Screening Scale (NU-DESC). NU-DESC consists of five items, each scored from 0 to 2 (total score: 0-10). A total NU-DESC score ≥ 2 was considered positive for delirium.

    Items:

    Disorientation Inappropriate behavior Inappropriate communication Illusions / hallucinations Psychomotor retardation

  5. RASS score profile

    Time frame: 0, 12, 24, 48, 72 hours

    Richmond Agitation-Sedation Scale distribution Sedation level was assessed using the Richmond Agitation-Sedation Scale (RASS).

    RASS scores were classified as:

    • 4 = combative,
    • 3 = very agitated,
    • 2 = agitated,
    • 1 = restless, 0 = alert and calm,
    • 1 = drowsy,
    • 2 = light sedation,
    • 3 = moderate sedation,
    • 4 = deep sedation,
    • 5 = unarousable.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Comparison of Postoperative Analgesic Effectiveness of Erector Spinae Plane Block and Combined With Superficial Parasternal Intercostal Plane Block Within the Enhanced Recovery After Cardiac Surgery (ERACS) Program: A Prospective, Randomized, Double-Blind Study

Acronym: ERACS-ESP-SPIP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2025
Registry last updated
Dec 31, 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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