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

September 27, 2025 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangzhou Women And Children's Medical Center
        • Contact:
          • Xingrong Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bupivacaine Liposome Injection
Drug: Bupivacaine Liposome Injection
Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Time Frame: 0 minute to 14 days after administration
Proportion of patients with any TEAE of cardiac or nervous system in MedDRA (Medical Dictionary for Regulatory Activities)
0 minute to 14 days after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Total consumption of opioids during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration.
0 minute to 72 hours after administration
Time to first rescue analgesia of opioid
Time Frame: 0 minute to 72 hours after administration
Duration from administration to first use of opioid for rescue analgesia.
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 who did not use rescue analgesia during 72 hours after administration.
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
The proportion of patients who used patient-controlled intravenous analgesia (PCIA) during 0-72 hours after administration.
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
Wong Baker Faces Pain Scale Revision (FPS-R，0 indicates no pain and 10 indicates the most severe pain) was used for children aged 6 to 7 years at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).
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
Numercal Rating Scale (0 indicates no pain and 10 indicates the most severe pain) was used for children aged 8 years and older to assess the intensity of pain at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).
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
Wong Baker Faces Pain Scale Revision (FPS-R，0 indicates no pain and 10 indicates the most severe pain) was used for children aged 6 to 7 years at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).
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
Numercal Rating Scale (0 indicates no pain and 10 indicates the most severe pain) was used for children aged 8 years and older to assess the intensity of pain at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).
0 minute to 72 hours after administration
Length of Stay
Time Frame: up to 2 weeks
The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged.
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZYWB-ZM-AHP-A-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Local Analgesia Via Infiltration

Clinical Trials on Bupivacaine Liposome Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings