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NCT Number: NCT07354750

Effect of Parasternal Plane Block on Intraoperative Nociception

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.

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Key information

Conditions

Median Sternotomy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parasternal Plane Block

Procedure

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

Procedure

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

Primary outcomes

  1. Intraoperative PAM Pain Index

    Time frame: While administering anesthesia during the procedure/surgery

    Comparison of intraoperative Pain Index Monitor (PAM) values between groups in pediatric patients undergoing cardiac surgery via median sternotomy. PAM Pain Index values will be recorded at predefined time points, including after induction of anesthesia, after block performance, at skin incision, during sternotomy, and during sternum closure.

Secondary outcomes

  1. Intraoperative Remifentanil Consumption

    Time frame: While administering anesthesia during the procedure/surgery

    Comparison of total intraoperative remifentanil consumption between groups

  2. Extubation Time

    Time frame: On the operation day

    Comparison of the time from the end of surgery to tracheal extubation between groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslı Dönmez

CONTACT

[email protected]

00905322256473

Elif Şule Özdemir Sezgi

CONTACT

[email protected]

00905059209638

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Effect of Parasternal Plane Block on Intraoperative Nociception in Pediatric Cardiac Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Feb 2, 2026

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.

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