En undersøgelse af bupivacain liposominjektion i lokal analgesi af pædiatriske patienter
En virkelig verden undersøgelse af lokal infiltration af bupivacain liposome injektion for akutte postoperative smerter efter pædiatrisk ortopædisk kirurgi
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Thea Yu
- Telefonnummer: +86-0518-82342973
- E-mail: suyang.yu.sy17@hengrui.com
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510000
- Rekruttering
- Guangzhou Women and Children's Medical Center
-
Kontakt:
- Xingrong Song
- E-mail: sxjess@126.com
-
Ledende efterforsker:
- Xingrong Song
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Bupivacain liposominjektion
|
Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ZYWB-ZM-AHP-A-003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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