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Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine

ConditionsDiaphragmatic FunctionMetacarpal FractureRadius FracturePeripheral Nerve NeurolysisChronic UlcerUpper Extremity Ligament Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing upper limb surgery scheduled for interscalene brachial plexus block

Aged ≥ 18 years

American Society of Anesthesiologists (ASA) physical status I-III

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.5% Hydrochloride Bupivacaine 20ml

    Drug

    0.5% Hydrochloride Bupivacaine 20ml for ISBPB

  • 0.5% Hydrochloride Bupivacaine 10ml

    Drug

    0.5% Hydrochloride Bupivacaine 10ml for ISBPB

  • Liposomal Bupivacaine 10mL

    Drug

    Liposomal Bupivacaine 10mL for ISBPB

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPBExperimental treatment 2 interventions
Group B: 0.5% Hydrochloride Bupivacaine (20ml) for ISBPBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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