Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine

Zhejiang University

Status: Not yet enrolling

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

Treatments: Drug: 0.5% Hydrochloride Bupivacaine 20ml; Drug: Liposomal Bupivacaine 10mL; Drug: 0.5% Hydrochloride Bupivacaine 10ml

Study type: Interventional

Funder types: Other

Identifiers

NCT07263295

ZJU_2025C116

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

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

Experimental group

Description:

ISBPB block group receiving combined administration of two drugs

Treatment:

Drug: 0.5% Hydrochloride Bupivacaine 10ml

Drug: Liposomal Bupivacaine 10mL

0.5% Hydrochloride Bupivacaine (20ml) for ISBPB

Active Comparator group

Description:

ISBPB block control group receiving single administration of a single drug

Treatment:

Drug: 0.5% Hydrochloride Bupivacaine 20ml