Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine

Evaluation of Diaphragmatic Function After Interscalene Brachial Plexus Block With Liposomal Bupivacaine: A Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metacarpal Fracture; Radius Fracture; Chronic Ulcer; Diaphragmatic Function; Peripheral Nerve Neurolysis; Upper Extremity Ligament Injury
• Intervention / Treatment: Drug: 0.5% Hydrochloride Bupivacaine 10ml; Drug: Liposomal Bupivacaine 10mL; Drug: 0.5% Hydrochloride Bupivacaine 20ml

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diansan Su, PhD; Phone Number: +8618616514088; Email: diansansu@yahoo.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, zhejiang 310000
      • Contact: Su Diansan Diansan Su, PhD; Phone Number: diansansu@yaho +8618616514088; Email: diansansu@yahoo.com

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB; ISBPB block group receiving combined administration of two drugs	Drug: 0.5% Hydrochloride Bupivacaine 10ml; 0.5% Hydrochloride Bupivacaine 10ml for ISBPB; Drug: Liposomal Bupivacaine 10mL; Liposomal Bupivacaine 10mL for ISBPB
Active Comparator: 0.5% Hydrochloride Bupivacaine (20ml) for ISBPB; ISBPB block control group receiving single administration of a single drug	Drug: 0.5% Hydrochloride Bupivacaine 20ml; 0.5% Hydrochloride Bupivacaine 20ml for ISBPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): December 5, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: September 27, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Liposomal Bupivacaine; Hemidiaphragmatic paralysis; Interscalene brachial plexus block
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Forearm Injuries; Radius Fractures; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: ZJU_2025C116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No