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)

Ankara University

Status: Completed

Conditions: Postoperative Pain Management; Sternotomy; Postoperative Delirium

Treatments: Procedure: Procedure: Erector Spinae Plane (ESP) Block; Procedure: Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07304635

ERACSDEL001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Arm 1: Erector Spinae Plane Block (Group E)

Experimental group

Description:

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.

Treatment:

Procedure: Procedure: Erector Spinae Plane (ESP) Block

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

Active Comparator group

Description:

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).

Treatment:

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