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

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Hengrui Medicine

Status and phase

Not yet enrolling
Phase 4

Conditions

Local Analgesia Via Infiltration

Treatments

Drug: Bupivacaine Liposome Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06344091
ZYWB-ZM-AHP-A-003

Details and patient eligibility

About

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.

Enrollment

232 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

232 participants in 1 patient group

Bupivacaine Liposome Injection
Experimental group
Treatment:
Drug: Bupivacaine Liposome Injection

Trial contacts and locations

1

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Central trial contact

Haibo Huang

Data sourced from clinicaltrials.gov

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