SBU Gazi Yasargil TRH
Diyarbakır, 210070, Turkey (Türkiye)
NCT Number: NCT07740915
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.
Interested in participating?
Request Info0 year–18 year
All sexes
Interventional
Not applicable
Diyarbakır, 210070, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: From the end of surgery up to 48 hours postoperatively
The time from the end of surgery until successful tracheal extubation will be recorded.
Time frame: Assessed at 0, 1, 2, 4, 8, 12, 18, and 24 hours postoperatively
Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale. FLACC scores will be recorded prospectively and compared between the Erector Spinae Plane Block (ESPB) and Modified Pectoral Fascial Plane Block (M-PFPB) groups
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Other
Comparison of the Analgesic Effects of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block in Pediatric Cardiac Surgery: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04672538
Anesthesia, Cardiovascular Abnormalities
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT04536194
Anesthesia, Cardiovascular Abnormalities
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT06642662
Cardiovascular Abnormalities, Cardiovascular Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT05610787
Cardiovascular Abnormalities, Cardiovascular Diseases
Los Angeles, California, United States
View Trial Details