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Recruiting NCT07263295

Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine

No phase Interventional Diaphragmatic Function Metacarpal Fracture Radius Fracture Peripheral Nerve Neurolysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 0.5% Hydrochloride Bupivacaine 20ml, 0.5% Hydrochloride Bupivacaine 10ml, Liposomal Bupivacaine 10mL.
Who it may be relevant to
Registry conditions: Diaphragmatic Function, Metacarpal Fracture, Radius Fracture, Peripheral Nerve Neurolysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Drug 0.5% Hydrochloride Bupivacaine 20ml
    0.5% Hydrochloride Bupivacaine 20ml for ISBPB
  • Drug 0.5% Hydrochloride Bupivacaine 10ml
    0.5% Hydrochloride Bupivacaine 10ml for ISBPB
  • Drug Liposomal Bupivacaine 10mL
    Liposomal Bupivacaine 10mL for ISBPB

Primary outcome measures

  • 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 outcome measures (3)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, zhejiang — Hangzhou

Identifiers

NCT: NCT07263295 · ZJU_2025C116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗