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Recruiting NCT06344091

A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients

Phase IV Interventional Local Analgesia Via Infiltration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine Liposome Injection.
Who it may be relevant to
Registry conditions: Local Analgesia Via Infiltration. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery

Overview

The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.

Interventions

  • Drug Bupivacaine Liposome Injection
    Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)

Primary outcome measures

  • The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system [Time frame: 0 minute to 14 days after administration]
Secondary outcome measures (9)
  • The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration [Time frame: 0 minute to 72 hours after administration]
  • Time to first rescue analgesia of opioid [Time frame: 0 minute to 72 hours after administration]
  • The proportion of patients who did not use rescue analgesia during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration [Time frame: 0 minute to 72 hours after administration]
  • The proportion of patients using patient-controlled intravenous analgesia (PCIA) [Time frame: 0 minute to 72 hours after administration]
  • Pain intensity score at rest after administration for children aged 6 to 7 years [Time frame: 0 minute to 72 hours after administration]
  • Pain intensity score at rest after administration for children aged 8 years and older [Time frame: 0 minute to 72 hours after administration]
  • Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years [Time frame: 0 minute to 72 hours after administration]
  • Pain intensity score on movement (or cough) after administration for children aged 8 years and older [Time frame: 0 minute to 72 hours after administration]
  • Length of Stay [Time frame: up to 2 weeks]

Eligibility criteria

Inclusion criteria

  • Subjects and guardians are willing to sign the informed consent.
  • Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm.
  • 6 years old ≤ age ≤17 years old , Male or female.
  • ASA Physical Status Classification I-III.

Exclusion criteria

  • Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days;
  • Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days;
  • Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate;
  • Subjects with a history of chronic pain or visceral pain;
  • Subjects with abnormal liver and kidney function;
  • Subjects with clinically significant abnormal heart rate or rhythm;
  • Subjects who are participating or planning to participate in any interventional clinical trial;
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Guangzhou Women and Children's Medical Center — Guangzhou

Identifiers

NCT: NCT06344091 · ZYWB-ZM-AHP-A-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗