Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07263295

Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diaphragmatic Function Arm Injuries Chronic Ulcer Forearm Injuries Fractures, Bone Metacarpal Fracture Peripheral Nerve Neurolysis Radius Fracture Radius Fractures Upper Extremity Ligament Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, zhejiang 310000

Hangzhou, Zhejiang, 310000, China

Location contact

Su Diansan Diansan Su, PhD

CONTACT

[email protected]

+8618616514088 ext. diansansu@yaho

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su, PhD

CONTACT

[email protected]

+8618616514088

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.