Liposomal Bupivacaine, Lung Transplantation, Pain Management
Conditions
Brief summary
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.
Interventions
DRUGLB/BH intercostal nerve block
Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.
DRUGBH intercostal nerve block
Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opioid consumption within 72 hours after surgery | 72 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS pain scores | 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. |
| Area under the curve of VAS pain scores | within 72 hours and 1 week after surgery | — |
| Quality of recovery | within 1 week after surgery | assessed using the QoR-15 scale |
| Sleep quality within 1 week after surgery | within 1 week after surgery | assessed using the Insomnia Severity Index (ISI) |
| Anxiety and depression | 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. |
| Length of ICU stay | within 90 days | — |
| total hospital stay | within 90 days | — |
| Incidence of chronic pain | at 3 months after surgery | Chronic pain was defined as the incidence of pain 3 months post-surgery, assessed using the VAS score. |
| sleep quality | at 3 months after surgery | Sleep quality was assessed using the Insomnia Severity Index. |
| anxiety and depression | at 3 months after surgery | assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD); |
| quality of recovery | at 3 months after surgery | ssessed using the QoR-15 scale |
| Incidence of adverse events | within 90 days | including nausea, vomiting, dizziness, infection, pneumothorax, and other complications. |
Countries
China
Contacts
CONTACTMin Yan
Outcome results
None listed