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

NCT07641647 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026-0791
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation; Pain Management; Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Opioid consumption within 72 hours after surgery

  72 hours after surgery

Secondary Outcomes (12)

• VAS pain scores

  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

  within 1 week after surgery

• Sleep quality within 1 week after surgery

  within 1 week after surgery

• Anxiety and depression

  within 1 week after surgery

Study Arms (2)

liposomal bupivacaine group

EXPERIMENTAL

Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride after surgery.

Drug: LB/BH intercostal nerve block

control group

ACTIVE COMPARATOR

Patients will receive an intercostal nerve block with bupivacaine hydrochloride after surgery.

Drug: BH intercostal nerve block

Interventions

LB/BH intercostal nerve block DRUG

Patients will receive an intercostal nerve block with a mixture of liposomal bupivacaine and bupivacaine hydrochloride immediately after lung transplantation.

liposomal bupivacaine group

BH intercostal nerve block DRUG

Patients will receive an intercostal nerve block with bupivacaine hydrochloride immediately after lung transplantation.

control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Min Yan

CONTACT

13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cheif of the Department of Anesthesiology, Second Affiliated Hospital of Zhejiang University

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)