The Effect of Bupivacaine Liposomes on Postoperative Pain... | NCT07641647

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

NCT07641647

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Not yet recruiting

Last Update Posted

Jun 11, 2026Actual

Enrollment

88Estimated

Phase

Phase 4

Conditions

Lung Transplantation
Pain Management
Liposomal Bupivacaine

Interventions

LB/BH intercostal nerve block
BH intercostal nerve block

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jul 1, 2028Estimated

Completion Date

Jul 1, 2028Estimated

First Submitted Date

May 28, 2026

First Submission Date that Met QC Criteria

Jun 7, 2026

First Posted Date

Jun 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2026

Last Update Posted Date

Jun 11, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Min Yan, Cheif of the Department of Anesthesiology, Second Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Yan	Contact	13757118632		zryanmin@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Zhejiang University anesthesiology department		Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms