Using ultrasound to manage pain in children after heart surgery
Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Fascial Block in Pediatric Cardiac Surgery
Başakşehir Çam & Sakura City Hospital · NCT06089798
This study is testing if a special ultrasound-guided pain relief technique can help children after heart surgery feel less pain and need fewer pain medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 82 (estimated) |
| Ages | 6 Months to 12 Years |
| Sex | All |
| Sponsor | Başakşehir Çam & Sakura City Hospital (other gov) |
| Locations | 1 site (Istanbul, Basaksehir) |
| Trial ID | NCT06089798 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the pecto-intercostal fascial block (PIFB) in reducing postoperative pain in pediatric patients undergoing congenital cardiac surgery. The trial compares two groups: one receiving the PIFB in addition to general anesthesia and the other receiving only general anesthesia. The study focuses on children aged 6 months to 12 years with specific ASA scores, assessing pain levels and opioid consumption post-surgery. The goal is to determine if the PIFB can enhance pain management and reduce opioid use in these patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 12 years undergoing congenital cardiac surgery with ASA scores of 2 or 3.
Not a fit: Patients requiring mechanical ventilation support before surgery or those with complex cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced opioid consumption in children undergoing cardiac surgery.
How similar studies have performed: While the specific application of PIFB in pediatric cardiac surgery is novel, similar regional anesthesia techniques have shown promise in managing postoperative pain in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass. * age between 6 months and 12 years * ASA score 2 or 3 * Risk Adjustment for Congenital Heart Surgery (RACHS-1) score under 4 Exclusion Criteria: * patients who need mechanical ventilation support before surgery * patients who need to stay intubated more than 24 hours after surgery * patients undergo complex cardiac surgery with RACHS-1 score higher than 4. * patients without consent * having allergic reaction to bupivacaine * having cardiac surgery before (redo patient)
Where this trial is running
Istanbul, Basaksehir
- Basaksehir Cam and Sakura City Hospital — Istanbul, Basaksehir, Turkey (RECRUITING)
Study contacts
- Study coordinator: selin sağlam
- Email: selinsaglams@gmail.com
- Phone: 0905557198756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Regional Anesthesia, pecto-intercostal fascial block, pediatric congenital cardiac surgery, postoperative pain management