Effect of Parasternal Plane Block on Intraoperative Nociception
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2026
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedStudy Start
First participant enrolled
January 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 17, 2026
February 2, 2026
January 1, 2026
6 months
January 12, 2026
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraoperative PAM Pain Index
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.
While administering anesthesia during the procedure/surgery
Secondary Outcomes (2)
Intraoperative Remifentanil Consumption
While administering anesthesia during the procedure/surgery
Extubation Time
On the operation day
Study Arms (2)
Parasternal Plane Block
ACTIVE COMPARATORPatients 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).
Group without peripheral nerve block
ACTIVE COMPARATORPatients in this arm will receive standard general anesthesia without regional anesthesia techniques. Intraoperative nociception will be monitored using the Pain Index Monitor (PAM).
Interventions
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.
Patients assigned to this group will undergo the surgical procedure under standard general anesthesia without the use of any peripheral nerve block techniques.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Etlik City Hospital
Ankara, 06000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal İnvestigator
Study Record Dates
First Submitted
January 12, 2026
First Posted
January 21, 2026
Study Start
January 30, 2026
Primary Completion (Estimated)
August 3, 2026
Study Completion (Estimated)
August 17, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01