Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine

NCT07263295 | Recruiting

• 1 other identifier: ZJU_2025C116
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Interscalene brachial plexus block; Liposomal Bupivacaine; Hemidiaphragmatic paralysis

Outcome Measures

Primary Outcomes (1)

• Identification the recovery time of diaphragmatic function after diaphragmatic paralysis caused by interscalene brachial plexus block

  From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours)

Secondary Outcomes (3)

• Identification the recovery time of pulmonary function after diaphragmatic paralysis

  From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours)

• Identification the Incidence of hemidiaphragmatic paralysis at different time points

  From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours)

• Identification the Proportion of pulmonary function recovery

  Time Frame: From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours)

Study Arms (2)

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

EXPERIMENTAL

ISBPB block group receiving combined administration of two drugs

Drug: 0.5% Hydrochloride Bupivacaine 10ml; Drug: Liposomal Bupivacaine 10mL

0.5% Hydrochloride Bupivacaine (20ml) for ISBPB

ACTIVE COMPARATOR

ISBPB block control group receiving single administration of a single drug

Drug: 0.5% Hydrochloride Bupivacaine 20ml

Interventions

0.5% Hydrochloride Bupivacaine 20ml DRUG

0.5% Hydrochloride Bupivacaine 20ml for ISBPB

0.5% Hydrochloride Bupivacaine (20ml) for ISBPB

0.5% Hydrochloride Bupivacaine 10ml DRUG

0.5% Hydrochloride Bupivacaine 10ml for ISBPB

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

Liposomal Bupivacaine 10mL DRUG

Liposomal Bupivacaine 10mL for ISBPB

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Radius Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Diansan Su

CONTACT

+8618616514088; diansansu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Patients and all outcome assessors responsible for diaphragmatic electromyography, pulmonary function testing, and pain score assessment were blinded to group allocation. Anesthesiologists performing the interscalene brachial plexus block and administering the study solutions were not blinded, due to the distinguishable appearance of the study formulations and the nature of the interventional procedure.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: December 4, 2025
• Study Start: December 5, 2025
• Primary Completion: August 20, 2026
• Study Completion: August 25, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CN (1)