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

NCT07304635 | Completed

• 1 other identifier: ERACSDEL001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sternotomy; Postoperative Pain Management; Postoperative Delirium

Keywords

sternotomy; post-sternotomy pain; postoperative pain; postoperative delirium; erector spinae plane blocks; superficial parasternal intercostal plane blocks

Outcome Measures

Primary Outcomes (1)

• VAS (resting)

  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 Outcomes (5)

• VAS (movement)

  0-72 hours

• Total rescue tramadol use (mg)

  0-72 hours

• Time to first rescue analgesic (min)

  0-72 hours

• Delirium incidence (Nu-DESC ≥ 2)

  12, 24, 48, 72 hours

• RASS score profile

  0, 12, 24, 48, 72 hours

Study Arms (2)

Arm 1: Erector Spinae Plane Block (Group E)

EXPERIMENTAL

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

Erector Spinae Plane Block + Superficial Parasternal Intercostal Plane Block (Group EP)

ACTIVE COMPARATOR

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

Interventions

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.

Erector Spinae Plane Block + Superficial Parasternal Intercostal Plane Block (Group EP)

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).

Arm 1: Erector Spinae Plane Block (Group E)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Interventions

Parapsychology; Dental Occlusion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be double-blind, meaning neither the researchers nor the participants will know which treatment group they belong to, ensuring unbiased outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is designed as a prospective, randomized, double-blind, parallel-group clinical trial conducted within the Enhanced Recovery After Cardiac Surgery (ERACS) program. A total of 42 adult patients undergoing elective cardiac surgery via median sternotomy will be randomized in a 1:1 ratio into two groups using a computer-generated randomization sequence and sealed opaque envelopes. Group E: Bilateral erector spinae plane (ESP) block Group EP: Bilateral ESP block combined with superficial parasternal intercostal plane (SPIP) block Both interventions will be performed under ultrasound guidance after induction of general anesthesia. Postoperative assessments-including VAS pain scores, sedation (RASS), and delirium screening (Nu-DESC)-will be recorded at standardized time points up to 72 hours after extubation. The study aims to compare postoperative analgesic effectiveness and the impact of pain control on postoperative delirium.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: August 30, 2024
• Primary Completion: July 27, 2025
• Study Completion: July 30, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)