The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management; Lung Transplantation; Liposomal Bupivacaine
• Intervention / Treatment: Drug: LB/BH intercostal nerve block; Drug: BH intercostal nerve block

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Yan; Phone Number: 13757118632; Email: zryanmin@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department
      • Contact: Min Yan; Phone Number: 13757118632; Email: zryanmin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: liposomal bupivacaine group; Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride after surgery.	Drug: LB/BH intercostal nerve block; Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.
Active Comparator: control group; Patients will receive an intercostal nerve block with bupivacaine hydrochloride after surgery.	Drug: BH intercostal nerve block; Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Opioid consumption within 72 hours after surgery	72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay		within 90 days
VAS pain scores	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		within 72 hours and 1 week after surgery
Quality of recovery	assessed using the QoR-15 scale	within 1 week after surgery
Sleep quality within 1 week after surgery	assessed using the Insomnia Severity Index (ISI)	within 1 week after surgery
Anxiety and depression	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		within 90 days
Incidence of chronic pain	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	Sleep quality was assessed using the Insomnia Severity Index.	at 3 months after surgery
anxiety and depression	assessed using the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale (HAMA/HAMD);	at 3 months after surgery
quality of recovery	ssessed using the QoR-15 scale	at 3 months after surgery
Incidence of adverse events	including nausea, vomiting, dizziness, infection, pneumothorax, and other complications.	within 90 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: 2026-0791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No