Effect of Parasternal Plane Block on Intraoperative Nociception
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parasternal Plane Block, Group without peripheral nerve block.
- Who it may be relevant to
- Registry conditions: Median Sternotomy, Pain Management. Basic parameters: 6 months — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Parasternal Plane Block on Intraoperative Nociception in Pediatric Cardiac Surgery
Overview
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.
Interventions
- Procedure 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. - Procedure 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.
Primary outcome measures
- Intraoperative PAM Pain Index [Time frame: While administering anesthesia during the procedure/surgery]
Secondary outcome measures (2)
- Intraoperative Remifentanil Consumption [Time frame: While administering anesthesia during the procedure/surgery]
- Extubation Time [Time frame: On the operation day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Ankara Etlik City Hospital — Ankara
Identifiers
NCT: NCT07354750 · AEŞH-EK-2026-010