Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine

N/ANot Yet RecruitingNCT07263295

Zhejiang University120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Diaphragmatic Function Metacarpal Fracture Radius Fracture Peripheral Nerve Neurolysis

Interventions

0.5% Hydrochloride Bupivacaine 20mlDRUG

0.5% Hydrochloride Bupivacaine 20ml for ISBPB

0.5% Hydrochloride Bupivacaine 10mlDRUG

0.5% Hydrochloride Bupivacaine 10ml for ISBPB

Liposomal Bupivacaine 10mLDRUG

Liposomal Bupivacaine 10mL for ISBPB

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Identification the recovery time of pulmonary function after diaphragmatic paralysis

Time frame: 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

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