Comparison of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block for Postoperative Analgesia in Pediatric Cardiac Surgery

NCT07740915 | Enrolling By Invitation

• 1 other identifier: 306
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain management is an essential component of perioperative care in pediatric congenital cardiac surgery. Regional anesthesia techniques, including the erector spinae plane block (ESPB) and modified pectoral fascial plane block (M-PFPB), are increasingly used as part of multimodal analgesia; however, evidence directly comparing these techniques in pediatric cardiac surgery remains limited. This prospective randomized controlled study aims to compare the analgesic efficacy of ESPB and M-PFPB in pediatric patients undergoing elective congenital cardiac surgery. The primary objective is to identify the regional anesthesia technique associated with more effective postoperative pain control. Secondary objectives include comparison of perioperative opioid consumption, hemodynamic parameters, extubation time, postoperative pain scores, perioperative complications, and intensive care unit and hospital length of stay. The findings are expected to contribute to the optimization of perioperative analgesia protocols and improve postoperative recovery in pediatric cardiac surgery.

Conditions

Congenital Heart Disease; Postoperative Pain After Cardiac Surgery Via Median Sternotomy; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Total Postoperative Opioid Consumption

  Total opioid consumption during the first 24 hours after surgery will be recorded and compared between the Erector Spinae Plane Block (ESPB) and Modified Pectoral Fascial Plane Block (M-PFPB) groups.

  24 hours postoperatively

Secondary Outcomes (2)

• Time to Extubation

  From the end of surgery up to 48 hours postoperatively

• Postoperative FLACC Pain Scores

  Assessed at 0, 1, 2, 4, 8, 12, 18, and 24 hours postoperatively

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Participants randomized to this group will receive an ultrasound-guided erector spinae plane block (ESPB) as part of multimodal perioperative analgesia before elective congenital cardiac surgery. Standard perioperative anesthesia and postoperative analgesia protocols will be applied to all participants

Procedure: Ultrasound-Guided Erector Spinae Plane Block

Modified Pectoral Fascial Plane Block

ACTIVE COMPARATOR

Participants randomized to this group will receive an ultrasound-guided modified pectoral fascial plane block (M-PFPB) as part of multimodal perioperative analgesia before elective congenital cardiac surgery. Standard perioperative anesthesia and postoperative analgesia protocols will be applied to all participants.

Procedure: Ultrasound-Guided Modified Pectoral Fascial Plane Block

Interventions

Ultrasound-Guided Erector Spinae Plane Block PROCEDURE

Ultrasound-guided erector spinae plane block will be performed bilaterally after induction of general anesthesia and before surgical incision to provide postoperative analgesia in pediatric patients undergoing congenital cardiac surgery.

Erector Spinae Plane Block

Ultrasound-Guided Modified Pectoral Fascial Plane Block PROCEDURE

Ultrasound-guided modified pectoral fascial plane block will be performed bilaterally after induction of general anesthesia and before surgical incision to provide postoperative analgesia in pediatric patients undergoing congenital cardiac surgery.

Modified Pectoral Fascial Plane Block

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients younger than 18 years of age.
• Scheduled for first-time elective congenital cardiac surgery.
• Written informed consent obtained from a parent or legal guardian.

You may not qualify if:

• Redo cardiac surgery.
• Emergency surgery.
• Contraindication to regional fascial plane block (e.g., infection at the injection site or allergy to local anesthetics).
• Coagulopathy.
• Chronic liver disease.
• Renal failure.
• History of opioid use before surgery.
• Failure to obtain written informed consent from a parent or legal guardian.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

SBU Gazi Yasargil TRH

Diyarbakır, Diyarbakır, 210070, Turkey (Türkiye)

Location

Related Publications (3)

• Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30.

  PMID: 32859487 BACKGROUND

• Kaushal B, Chauhan S, Magoon R, Krishna NS, Saini K, Bhoi D, Bisoi AK. Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy. J Cardiothorac Vasc Anesth. 2020 Apr;34(4):981-986. doi: 10.1053/j.jvca.2019.08.009. Epub 2019 Aug 12.

  PMID: 31515190 BACKGROUND

• Macaire P, Ho N, Nguyen V, Phan Van H, Dinh Nguyen Thien K, Bringuier S, Capdevila X. Bilateral ultrasound-guided thoracic erector spinae plane blocks using a programmed intermittent bolus improve opioid-sparing postoperative analgesia in pediatric patients after open cardiac surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2020 Oct;45(10):805-812. doi: 10.1136/rapm-2020-101496. Epub 2020 Aug 19.

  PMID: 32817407 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated proffessor

Model Details: This is a prospective, randomized, parallel-group, single-center clinical trial comparing the analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Modified Pectoral Fascial Plane Block (M-PFPB) in pediatric patients undergoing elective congenital cardiac surgery. Eligible participants will be randomly assigned in a 1:1 ratio to one of the two intervention groups. Clinical outcomes will be prospectively evaluated and compared between the groups.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 3, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)