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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine Liposome Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Liposome Injection | Drug | Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0 minute to 14 days after administration |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thea Yu | Contact | +0518-82342973 | suyang.yu.sy17@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Women and Children's Medical Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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A single-arm study of liposomal bupivacaine injection
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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 | 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) | 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 | 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 | 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 | 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 | 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 | The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged. | up to 2 weeks |