Effect of Parasternal Plane Block on Intraoperative Nociception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-7
SponsorDiskapi Yildirim Beyazit Education and Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Parasternal Plane Block
Procedure/SurgeryUltrasound-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/SurgeryPatients assigned to this group will undergo the surgical procedure under standard general anesthesia without the use of any peripheral nerve block techniques.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Parasternal Plane BlockActive comparator 1 intervention
Group B: Group without peripheral nerve blockActive comparator 1 intervention
Trial outcomes
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.
Time frame
While administering anesthesia during the procedure/surgerySecondary outcomes
1
Intraoperative Remifentanil Consumption
Comparison of total intraoperative remifentanil consumption between groups
Time frame
While administering anesthesia during the procedure/surgery2
Extubation Time
Comparison of the time from the end of surgery to tracheal extubation between groups.
Time frame
On the operation daySponsors and contacts
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Diskapi Yildirim Beyazit Education and Research Hospital
Lead sponsor
Ankara Etlik City Hospital
Sponsor institution
Source ClinicalTrials.gov