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

NCT ID: NCT07304635

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2025-07-30

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.

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.

Conditions

Sternotomy; Postoperative Delirium; Postoperative Pain Management

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Procedure: Erector Spinae Plane (ESP) Block

Intervention Type: 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 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).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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 chronic pain history or regular analgesic use Provided written informed consent after detailed explanation of the study

Exclusion Criteria

Age <18 or >80 years ASA ≥ IV Emergency surgery Pregnant or breastfeeding women Redo coronary artery bypass surgery Pre-existing cognitive disorder or psychiatric illness affecting pain/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 Patients unwilling to participate or withdraw consent at any stage

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

FATMA CANDAN YEREBAKAN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara University Faculty of Medicine

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ERACSDEL001

Identifier Type: -

Identifier Source: org_study_id