Local Analgesia Via Infiltration
Conditions
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.
Interventions
Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A single-arm study of liposomal bupivacaine injection
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue analgesia of opioid | 0 minute to 72 hours after administration | Duration from administration to first use of opioid for rescue analgesia. |
| 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 | 0 minute to 72 hours after administration | The proportion of patients who did not use rescue analgesia during 72 hours after administration. |
| The proportion of patients using patient-controlled intravenous analgesia (PCIA) | 0 minute to 72 hours after administration | The proportion of patients who used patient-controlled intravenous analgesia (PCIA) during 0-72 hours after administration. |
| Pain intensity score at rest after administration for children aged 6 to 7 years | 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). |
| The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration | 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. |
| Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years | 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). |
| Pain intensity score on movement (or cough) after administration for children aged 8 years and older | 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). |
| Length of Stay | up to 2 weeks | The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged. |
| Pain intensity score at rest after administration for children aged 8 years and older | 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). |
Countries
China
Contacts
Primary ContactThea Yu
Outcome results
None listed