En studie av bupivacain-liposominjektion i lokal smärtlindring av pediatriska patienter
En verklig studie om lokal infiltration av bupivacain liposominjektion för akut postoperativ smärta efter pediatrisk ortopedisk 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Thea Yu
- Telefonnummer: +86-0518-82342973
- E-post: suyang.yu.sy17@hengrui.com
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510000
- Rekrytering
- Guangzhou Women and Children's Medical Center
-
Kontakt:
- Xingrong Song
- E-post: sxjess@126.com
-
Huvudutredare:
- Xingrong Song
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Bupivacaine Liposome Injection
|
Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ZYWB-ZM-AHP-A-003
Plan för individuella deltagardata (IPD)
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