Comparison of the Analgesic Effects of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block in Pediatric Cardiac Surgery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Total Postoperative Opioid Consumption
Study Overview
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.
Detailed Description
Effective postoperative analgesia is a key determinant of recovery following pediatric congenital cardiac surgery. Adequate pain control may reduce opioid requirements, facilitate early extubation, decrease perioperative complications, and improve overall postoperative outcomes. Among the regional anesthesia techniques used in pediatric cardiac surgery, erector spinae plane block (ESPB) and modified pectoral fascial plane block (M-PFPB) have gained increasing attention because of their potential to provide effective analgesia while minimizing opioid exposure.
This prospective randomized controlled trial is designed to compare the analgesic efficacy of ESPB and M-PFPB in pediatric patients undergoing first-time elective congenital cardiac surgery. Patients younger than 18 years who meet the eligibility criteria will be enrolled after written informed consent has been obtained from their parents or legal guardians.
Demographic characteristics, including age, sex, body mass index, ASA physical status, and cardiac diagnosis, will be recorded. Perioperative variables, including cardiopulmonary bypass duration, aortic cross-clamp time, duration of surgery, duration of anesthesia, intraoperative and postoperative opioid consumption, intraoperative hemodynamic parameters (heart rate, blood pressure, near-infrared spectroscopy, and oxygen saturation), extubation time, postoperative FLACC pain scores, perioperative complications, intensive care unit length of stay, and hospital length of stay, will be prospectively collected and analyzed.
The primary objective of the study is to determine which regional anesthesia technique provides more effective postoperative analgesia in pediatric congenital cardiac surgery. Secondary objectives include comparison of opioid requirements, postoperative recovery parameters, and perioperative complications between the two study groups. The study findings are expected to support the development of evidence-based perioperative analgesia protocols for pediatric cardiac surgery and contribute to the current literature.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 0 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Total Postoperative Opioid Consumption
Time Frame: 24 hours postoperatively
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.
Secondary Outcomes
- 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)
Investigators
Mustafa Bıçak
Associated proffessor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital