Status:

RECRUITING

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

Lead Sponsor:

Jiangsu HengRui Medicine Co., Ltd.

Conditions:

Local Analgesia Via Infiltration

Eligibility:

All Genders

6-17 years

Phase:

PHASE4

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Key Trial Info

Start Date :

May 21 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 12 2026

Estimated Enrollment :

232 Patients enrolled

Trial Details

Trial ID

NCT06344091

Start Date

May 21 2024

End Date

October 12 2026

Last Update

October 2 2025

Active Locations (1)

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1

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China, 510000

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