Local Analgesia Via InfiltrationPhase 4NCT06344091
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
A Phase 4 study testing Bupivacaine Liposome Injection in people with Local Analgesia Via Infiltration, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Local Analgesia Via Infiltration
- What is being tested?
- Bupivacaine Liposome Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2024to May 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510000
Xingrong Song, sxjess@126.com
Xingrong Song
About this study
Official title: 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.
- Conditions
- Local Analgesia Via Infiltration
- Being tested
- Bupivacaine Liposome Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Liposome InjectionDrug
Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Liposome Injection | Experimental | Not described Receives: Drug: Bupivacaine Liposome Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Proportion of patients with any TEAE of cardiac or nervous system in MedDRA (Medical Dictionary for Regulatory Activities).
Measured: 0 minute to 14 days after administration
Secondary outcomes (9)
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
Total consumption of opioids during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration.
Measured: 0 minute to 72 hours after administration
Time to first rescue analgesia of opioid
Duration from administration to first use of opioid for rescue analgesia.
Measured: 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
The proportion of patients who did not use rescue analgesia during 72 hours after administration.
Measured: 0 minute to 72 hours after administration
The proportion of patients using patient-controlled intravenous analgesia (PCIA)
The proportion of patients who used patient-controlled intravenous analgesia (PCIA) during 0-72 hours after administration.
Measured: 0 minute to 72 hours after administration
Pain intensity score at rest after administration for children aged 6 to 7 years
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).
Measured: 0 minute to 72 hours after administration
Pain intensity score at rest after administration for children aged 8 years and older
Numerical 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).
Measured: 0 minute to 72 hours after administration
Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years
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).
Measured: 0 minute to 72 hours after administration
Pain intensity score on movement (or cough) after administration for children aged 8 years and older
Numerical 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).
Measured: 0 minute to 72 hours after administration
Length of Stay
The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start21 May 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Analgesia Via InfiltrationStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm study of liposomal bupivacaine injection
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344091
- Sponsor's protocol ID
- ZYWB-ZM-AHP-A-003
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided