Parasternal plane block to reduce pain signals during pediatric median sternotomy
Official title: Effect of Parasternal Plane Block on Intraoperative Nociception in Pediatric Cardiac Surgery
Run by Diskapi Yildirim Beyazit Education and Research Hospital · NCT07354750 · Data updated 2026-11-12
This will test whether an ultrasound-guided parasternal plane block can reduce intraoperative pain signals in children aged 6 months to 7 years undergoing heart surgery with a median sternotomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 7 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Diskapi Yildirim Beyazit Education and Research Hospital Government |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | January 30, 2026 |
| Main results expected | August 3, 2026 |
| Study ends | August 17, 2026 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT07354750 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6 months to 7 years scheduled for elective congenital cardiac surgery with planned median sternotomy, ASA physical status II–III, hemodynamically stable, and with parent or guardian consent are eligible.
✕Probably not a fit
Patients undergoing emergency or redo sternotomy, those outside the 6 months–7 years age range, ASA I or >III, with severe neurological disorders, or without parental consent are unlikely to qualify or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized trial in pediatric patients undergoing elective congenital cardiac surgery via median sternotomy that compares ultrasound-guided parasternal plane block to no peripheral nerve block. Intraoperative nociception will be measured objectively using the Pain Index Monitor (PAM), which records skin conductance changes, alongside routine hemodynamic monitoring. The protocol records opioid requirements, hemodynamic stability, and markers of recovery such as time to extubation and ICU course. The trial aims to determine whether adding the parasternal plane block meaningfully lowers nociceptive signals and related clinical endpoints during surgery.
Why it matters
Potential benefit: If successful, the block could lower intraoperative nociception, reduce opioid needs, and improve perioperative stability and recovery for children having median sternotomy.
How similar studies have gone: Regional parasternal/pectoral plane blocks have shown promise in adult and pediatric case series for reducing postoperative pain, but randomized data using objective intraoperative nociception monitors are still limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Elif Şule Özdemir Sezgi
- Email: elifsule-91@hotmail.com
- Phone: 00905059209638
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.