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Safety and Efficacy of Bupivacaine Liposome Injection for Postoperative Pain Management in Pediatric Congenital Heart Disease Surgeries: A Single-Center, Prospective, Observational Study

Safety and Efficacy of Bupivacaine Liposome Injection for Postoperative Pain Management in Pediatric Congenital Heart Disease Surgeries: A Single-Center, Prospective, Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115761
Enrollment
Unknown
Registered
2025-12-31
Start date
2026-01-08
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Children with congenital heart disease

Interventions

Bupivacaine liposome group:After anesthesia, anterior serratus nerve block was performed with 0.25% bupivacaine liposomes at a dose of 0.4ml/kg
Ropivacaine group:After anesthesia, anterior serratus nerve block was performed at a concentration of 0.25% ropivacaine and a dose of 0.5ml/kg
Control group:Perform anterior serratus nerve block after anesthesia and administer physiological saline

Sponsors

Fuwai Central China Cardiovascular Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.0-18 years old 2. Planned surgery for congenital heart disease under general anesthesia 3. ASA (II-IV level) 4. Parents voluntarily sign an informed consent form

Exclusion criteria

Exclusion criteria: 1.Patients with combined mental system disorders and cognitive dysfunction; 2. Known allergy to bupivacaine or other amide local anesthetics 3. Severe liver and kidney dysfunction 4. Patients with chest deformities who cannot undergo nerve block 5. Infected individuals at the puncture site

Design outcomes

Primary

MeasureTime frame
The dosage of sufentanil per kilogram of body weight during surgery and within 72 hours after surgery;

Secondary

MeasureTime frame
Flacc pain score, Ramsay sedation score;Heart rate and mean arterial blood pressure;The time of first compression of the analgesic pump (counted from the time of extubation after surgery), the total number of compressions of the analgesic pump within 72 hours after surgery, and the effective number of compressions of the analgesic pump within 72 hours after surgery;

Countries

China

Contacts

Public ContactHongqi Lin

Fuwai Central China Cardiovascular Hospita

lhq9988@126.com+86 135 2358 3033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026