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

December 25, 2025 updated by: FATMA CANDAN YEREBAKAN, Ankara University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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)
      • Ankara, Turkey (Türkiye), 06230
        • Ankara University Faculty of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Erector Spinae Plane Block (Group E)

After induction of general anesthesia, patients will receive a bilateral ultrasound-guided erector spinae plane block at the T4--T5 vertebral level.

A total of 30 mL of 0.25% bupivacaine per side (prepared as 10 mL saline + 10 mL 0.5% bupivacaine per syringe) will be injected into the deep fascial plane beneath the erector spinae muscle using an 80 mm block needle under aseptic conditions.

The spread of the local anesthetic will be observed in a craniocaudal direction in real time. The procedure will be repeated bilaterally.

All patients will subsequently receive standardized postoperative analgesia with paracetamol 1 g IV every 6 hours; if VAS > 4, tramadol 50 mg IV will be given as rescue analgesia.
Procedure: Procedure: Erector Spinae Plane (ESP) Block

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).
Active Comparator: Erector Spinae Plane Block + Superficial Parasternal Intercostal Plane Block (Group EP)

Following induction of general anesthesia, patients will receive a bilateral ESP block (same technique as in Group E) with 20 mL of 0.25% bupivacaine per side.

Afterward, a bilateral superficial parasternal intercostal plane block (SPIP) will be performed in the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe and 80 mm block needle.

After confirming negative aspiration and hydrodissection with 1-3 mL saline, 10 mL of 0.25% bupivacaine per side will be injected into the interfacial plane.

The total local anesthetic volume for both blocks combined will be 60 mL, kept below the toxic threshold.

Standard postoperative analgesia will be identical to Group E (paracetamol 1 g IV every 6 hours, and tramadol 50 mg IV if VAS > 4).
Procedure: Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 72 hours post-extubation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS (movement)
Time Frame: 0-72 hours
Mean VAS scores during movement at all time points
0-72 hours
Total rescue tramadol use (mg)
Time Frame: 0-72 hours
Cumulative IV tramadol dose
0-72 hours
Time to first rescue analgesic (min)
Time Frame: 0-72 hours
Time between extubation and first rescue tramadol
0-72 hours
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
12, 24, 48, 72 hours
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.
0, 12, 24, 48, 72 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERACSDEL001

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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Conditions

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Drug Interventions

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