The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled Study
7. juni 2026 oppdatert av: Min Yan, Second Affiliated Hospital, School of Medicine, Zhejiang University
The goal of this clinical trial is to evaluate the efficacy and safety of liposomal bupivacaine for postoperative analgesia in adult patients undergoing lung transplantation. The main questions it aims to answer are:
Does liposomal bupivacaine reduce postoperative opioid consumption after lung transplantation? Does liposomal bupivacaine relieve postoperative pain without increasing adverse events?
Researchers will compare patients receiving liposomal bupivacaine combined with bupivacaine hydrochloride with patients receiving bupivacaine hydrochloride alone to see whether liposomal bupivacaine provides better postoperative analgesia and reduces opioid requirements after lung transplantation.
Participants will:
Receive lung transplantation under standard perioperative care. Receive intercostal nerve block with either liposomal bupivacaine combined with bupivacaine hydrochloride or bupivacaine hydrochloride alone.
Be assessed for postoperative opioid consumption, pain scores, recovery-related outcomes, and adverse events after surgery.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
88
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Min Yan
- Telefonnummer: 13757118632
- E-post: zryanmin@zju.edu.cn
Studiesteder
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310000
- The Second Affiliated Hospital of Zhejiang University anesthesiology department
-
Ta kontakt med:
- Min Yan
- Telefonnummer: 13757118632
- E-post: zryanmin@zju.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients with end-stage lung disease undergoing bilateral lung transplantation; Age >18 years; Expected discontinuation of mechanical ventilation within 48 hours after surgery; The patient or legally authorized representative signs the informed consent form and agrees to participate in the study and follow-up.
Exclusion Criteria:
- Body mass index ≤18 kg/m² or ≥35 kg/m²; Allergy or contraindication to local anesthetics; Preoperative tracheal intubation or requirement for extracorporeal life support; Expected use of other types of nerve block; Active systemic infection or infection at the planned block site; Severe hepatic insufficiency; Severe renal impairment; Chronic pain, neuropathic pain, long-term use of analgesics, or use of other psychotropic medications; Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric disorders; Severe coagulation dysfunction; Concomitant surgery during the same operative session; Pregnant or breastfeeding women.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: liposomal bupivacaine group
Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride after surgery.
|
Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.
|
|
Aktiv komparator: control group
Patients will receive an intercostal nerve block with bupivacaine hydrochloride after surgery.
|
Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Opioid consumption within 72 hours after surgery
Tidsramme: 72 hours after surgery
|
72 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lengde på intensivavdelingen
Tidsramme: innen 90 dager
|
innen 90 dager
|
|
|
VAS pain scores
Tidsramme: at 24 hours, 48 hours, 72 hours, and 1 week after surgery;
|
ranging from 0 to 100 mm, with 0 indicating no pain and 100 indicating the worst imaginable pain.
|
at 24 hours, 48 hours, 72 hours, and 1 week after surgery;
|
|
Area under the curve of VAS pain scores
Tidsramme: within 72 hours and 1 week after surgery
|
within 72 hours and 1 week after surgery
|
|
|
Quality of recovery
Tidsramme: within 1 week after surgery
|
assessed using the QoR-15 scale
|
within 1 week after surgery
|
|
Sleep quality within 1 week after surgery
Tidsramme: within 1 week after surgery
|
assessed using the Insomnia Severity Index (ISI)
|
within 1 week after surgery
|
|
Anxiety and depression
Tidsramme: within 1 week after surgery
|
Anxiety and depression symptoms were assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD), respectively, with HAMA ranging from 0 to 56 and HAMD ranging from 0 to 52.
|
within 1 week after surgery
|
|
total hospital stay
Tidsramme: within 90 days
|
within 90 days
|
|
|
Incidence of chronic pain
Tidsramme: at 3 months after surgery
|
Chronic pain was defined as the incidence of pain 3 months post-surgery, assessed using the VAS score.
|
at 3 months after surgery
|
|
sleep quality
Tidsramme: at 3 months after surgery
|
Sleep quality was assessed using the Insomnia Severity Index.
|
at 3 months after surgery
|
|
anxiety and depression
Tidsramme: at 3 months after surgery
|
assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD);
|
at 3 months after surgery
|
|
quality of recovery
Tidsramme: at 3 months after surgery
|
ssessed using the QoR-15 scale
|
at 3 months after surgery
|
|
Incidence of adverse events
Tidsramme: within 90 days
|
including nausea, vomiting, dizziness, infection, pneumothorax, and other complications.
|
within 90 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. juli 2028
Studiet fullført (Antatt)
1. juli 2028
Datoer for studieregistrering
Først innsendt
28. mai 2026
Først innsendt som oppfylte QC-kriteriene
7. juni 2026
Først lagt ut (Faktiske)
11. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-0791
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .