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Clinical Trials in Turkey / NCT07354750
Recruiting Not applicable

Effect of Parasternal Plane Block on Intraoperative Nociception

NCT07354750 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-01-30
Last updated
2026-02-02

Condition(s) studied

Median SternotomyPain Management

Investigational drug(s) / intervention(s)

Parasternal Plane BlockGroup without peripheral nerve block

Parasternal Plane Block: Ultrasound-guided bilateral parasternal plane block will be performed after induction of general anesthesia. The block will be performed after induction of anesthesia using 0.25% bupivacaine, with a total dose of 1.5 mg/kg, administered in equal volumes to both sides. The procedure will be carried out by experienced anesthesiologists under sterile conditions.

Group without peripheral nerve block: Patients assigned to this group will undergo the surgical procedure under standard general anesthesia without the use of any peripheral nerve block techniques.

Study summary

Effective pain control during pediatric cardiac surgery remains a major clinical challenge, particularly in procedures involving median sternotomy, which is associated with intense nociceptive stimulation. Inadequate intraoperative analgesia may lead to increased opioid requirements, hemodynamic instability, delayed extubation, and prolonged intensive care unit stay. Objective monitoring of nociception may provide valuable information beyond conventional hemodynamic parameters in this vulnerable population.

This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided parasternal plane block on intraoperative nociception in pediatric patients undergoing cardiac surgery with median sternotomy. Intraoperative nociception will be objectively assessed using the Pain Index Monitor (PAM), based on skin conductance measurements.

The results of this study are expected to provide objective evidence regarding the efficacy of parasternal plane block in attenuating nociceptive responses during pediatric cardiac surgery and to support the integration of regional anesthesia techniques and objective nociception monitoring into perioperative pain management strategies for children.

Eligibility

Sex
ALL
Min age
6 Months
Max age
7 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 6 months and 7 years * Scheduled for elective congenital cardiac surgery * Planned median sternotomy * American Society of Anesthesiologists (ASA) physical status II-III * Hemodynamically stable preoperative condition * Written informed consent obtained from a parent or legal guardian Exclusion Criteria: * Emergency surgery or redo sternotomy * Age \<6 months or \>7 years * ASA physical status I or \>III * Severe neurological disorders preventing reliable application of behavioral pain scales * Failure to obtain written informed consent from a parent or legal guardian

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ankara Etlik City Hospital Ankara Turkey (Türkiye) Recruiting

More Diskapi Yildirim Beyazit Education and Research Hospital trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07354750 on ClinicalTrials.gov ↗ ← All trials in Turkey