About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
LB/BH intercostal nerve block
DrugPatients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.
BH intercostal nerve block
DrugPatients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.
Treatment groups
Trial outcomes
Primary outcomes
Opioid consumption within 72 hours after surgery
Secondary outcomes
VAS pain scores
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
Quality of recovery
assessed using the QoR-15 scale
Sleep quality within 1 week after surgery
assessed using the Insomnia Severity Index (ISI)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: