Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine

NCT ID: NCT07263295

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-05

Study Completion Date

2026-12-20

Brief Summary

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The study aims to evaluation the effects of Liposomal Bupivacaine on diaphragmatic function in patients undergoing upper limb surgery who receive Interscalene Brachial Plexus Block. A total of 120 eligible patients will be enrolled and divided into two groups: Group A will receive 20ml of 0.5% Hydrochloride Bupivacaine , while Group B will receive 10ml of 0.5% Hydrochloride Bupivacaine plus 10ml of Liposomal Bupivacaine. Assessments of diaphragmatic function, pulmonary function, and pain intensity will be performed before the block and at different time points after the block, with follow-up for adverse events. The study is scheduled to run from September 2025 to September 2026, with strict adherence to privacy protection and ethical guidelines.

Detailed Description

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Conditions

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Diaphragmatic Function Metacarpal Fracture Radius Fracture Peripheral Nerve Neurolysis Chronic Ulcer Upper Extremity Ligament Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB

ISBPB block group receiving combined administration of two drugs

Group Type EXPERIMENTAL

0.5% Hydrochloride Bupivacaine 10ml

Intervention Type DRUG

0.5% Hydrochloride Bupivacaine 10ml for ISBPB

Liposomal Bupivacaine 10mL

Intervention Type DRUG

Liposomal Bupivacaine 10mL for ISBPB

0.5% Hydrochloride Bupivacaine (20ml) for ISBPB

ISBPB block control group receiving single administration of a single drug

Group Type ACTIVE_COMPARATOR

0.5% Hydrochloride Bupivacaine 20ml

Intervention Type DRUG

0.5% Hydrochloride Bupivacaine 20ml for ISBPB

Interventions

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0.5% Hydrochloride Bupivacaine 20ml

0.5% Hydrochloride Bupivacaine 20ml for ISBPB

Intervention Type DRUG

0.5% Hydrochloride Bupivacaine 10ml

0.5% Hydrochloride Bupivacaine 10ml for ISBPB

Intervention Type DRUG

Liposomal Bupivacaine 10mL

Liposomal Bupivacaine 10mL for ISBPB

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing upper limb surgery scheduled for interscalene brachial plexus block
* Aged ≥ 18 years
* American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria

* Known allergy or intolerance to amide local anesthetics
* Nerve injury in the upper limb on the surgical side
* Coagulopathy
* Used opioid medications continuously for more than 3 weeks before surgery
* History of pulmonary disease and a pulse oxygen saturation (SpO₂) \< 95% (measured after 5 minutes of rest at room temperature without oxygen supplementation, using a transcutaneous pulse oximeter)
* Refuse to participate or are deemed unsuitable for this trial by the researchers

Withdrawal Criteria:

* Patients voluntarily withdrew their informed consent
* Surgery was canceled or the anesthesia method was changed due to surgical factors before interscalene brachial plexus block
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Diansan Su

Chair of the Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, zhejiang 310000

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Diansan Su, PhD

Role: CONTACT

+8618616514088

Facility Contacts

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Su Diansan Diansan Su, PhD

Role: primary

+8618616514088 ext. diansansu@yaho

Other Identifiers

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ZJU_2025C116

Identifier Type: -

Identifier Source: org_study_id

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