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Effect of Parasternal Plane Block on Intraoperative Nociception

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07354750
Enrollment
60
Registered
2026-01-21
Start date
2026-01-30
Completion date
2026-08-17
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Median Sternotomy, Pain Management

Keywords

Median Sternotomy, Parasternal Plane Block

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.

Interventions

PROCEDUREParasternal 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.

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

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative PAM Pain IndexWhile administering anesthesia during the procedure/surgeryComparison 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

MeasureTime frameDescription
Intraoperative Remifentanil ConsumptionWhile administering anesthesia during the procedure/surgeryComparison of total intraoperative remifentanil consumption between groups
Extubation TimeOn the operation dayComparison of the time from the end of surgery to tracheal extubation between groups.

Countries

Turkey (Türkiye)

Contacts

CONTACTElif Şule Özdemir Sezgi
elifsule-91@hotmail.com00905059209638
CONTACTAslı Dönmez
aslidonmez@hotmail.com00905322256473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026