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RecruitingNCT07354750Updated Feb 2, 2026

Effect of Parasternal Plane Block on Intraoperative Nociception

An interventional study of Parasternal Plane Block and Group without peripheral nerve block in Median Sternotomy and Pain Management, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Months to 7 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Months to 7 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Median Sternotomy
  • Pain Management

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Keywords

  • Median Sternotomy
  • Parasternal Plane Block
03

Who can participate

Ages eligible
6 Months to 7 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Parasternal Plane Block

    Patients 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).

    Procedure: Parasternal Plane Block

  • Active comparator
    Group without peripheral nerve block

    Patients in this arm will receive standard general anesthesia without regional anesthesia techniques. Intraoperative nociception will be monitored using the Pain Index Monitor (PAM).

    Procedure: Group without peripheral nerve block

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.

  • ProcedureGroup 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.

05

What researchers measure

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/surgery

Secondary outcomes

  1. Intraoperative Remifentanil Consumption

    Comparison of total intraoperative remifentanil consumption between groups

    Time frame: While administering anesthesia during the procedure/surgery

  2. Extubation Time

    Comparison of the time from the end of surgery to tracheal extubation between groups.

    Time frame: On the operation day

06

Study locations

1 of 1 sites recruiting
  • Ankara Etlik City Hospital
    Ankara, 06000, Turkey (Türkiye)
    Recruiting
07

Registry details

Key details

Study ID
NCT07354750
Lead sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Responsible party
Elif Sule Ozdemir (Principal İnvestigator, Ankara Etlik City Hospital) — Principal investigator
First posted
Jan 21, 2026
Start date
Jan 30, 2026
Primary completion
Aug 3, 2026 (estimated)
Completion
Aug 17, 2026 (estimated)
Last update
Feb 2, 2026

Study contacts

Elif Şule Özdemir Sezgi
Contact
elifsule-91@hotmail.com
00905059209638
Aslı Dönmez
Contact
aslidonmez@hotmail.com
00905322256473

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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