Een onderzoek naar bupivacaïne-liposoominjectie bij lokale analgesie bij pediatrische patiënten
Een praktijkonderzoek naar lokale infiltratie van bupivacaïne-liposoominjectie voor acute postoperatieve pijn na pediatrische orthopedische chirurgie
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Thea Yu
- Telefoonnummer: +86-0518-82342973
- E-mail: suyang.yu.sy17@hengrui.com
Studie Locaties
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Werving
- Guangzhou Women and Children's Medical Center
-
Contact:
- Xingrong Song
- E-mail: sxjess@126.com
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Hoofdonderzoeker:
- Xingrong Song
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Bupivacaïne liposoominjectie
|
Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0 minute to 72 hours after administration
|
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). |
0 minute to 72 hours after administration
|
|
Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years
Tijdsspanne: 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
Tijdsspanne: 0 minute to 72 hours after administration
|
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). |
0 minute to 72 hours after administration
|
|
Length of Stay
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- ZYWB-ZM-AHP-A-003
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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