Effect of Parasternal Plane Block on Intraoperative Nociception

Diskapi Yildirim Beyazit Training and Research Hospital

Status: Enrolling

Conditions: Median Sternotomy; Pain Management

Treatments: Procedure: Parasternal Plane Block; Procedure: Group without peripheral nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT07354750

AEŞH-EK-2026-010

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Parasternal Plane Block

Active Comparator group

Description:

Patients in this arm will receive standard general anesthesia combined with ultrasound-guided bilateral parasternal plane block. 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. Intraoperative nociception will be monitored using the Pain Index Monitor (PAM).

Treatment:

Procedure: Parasternal Plane Block

Group without peripheral nerve block

Active Comparator group

Description:

Patients in this arm will receive standard general anesthesia without regional anesthesia techniques. Intraoperative nociception will be monitored using the Pain Index Monitor (PAM).

Treatment:

Procedure: Group without peripheral nerve block