Diaphragmatic FunctionNCT07263295
Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
A study testing 0.5% Hydrochloride Bupivacaine 20ml, 0.5% Hydrochloride Bupivacaine 10ml and Liposomal Bupivacaine 10mL in people with Diaphragmatic Function and Metacarpal Fracture, run by Zhejiang University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragmatic Function, Metacarpal Fracture, Radius Fracture
- What is being tested?
- 0.5% Hydrochloride Bupivacaine 20ml, 0.5% Hydrochloride Bupivacaine 10ml and Liposomal Bupivacaine 10mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2025to 25 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing upper limb surgery scheduled for interscalene brachial plexus block
- Aged ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I-III
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, zhejiang 310000
Hangzhou, Zhejiang, 310000
Su Diansan Diansan Su, PhD, +8618616514088 ext. diansansu@yaho, diansansu@yahoo.com
About this study
Official title: Evaluation of Diaphragmatic Function After Interscalene Brachial Plexus Block With Liposomal Bupivacaine: A Cohort Study
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.
- Conditions
- Diaphragmatic Function, Metacarpal Fracture, Radius Fracture, Peripheral Nerve Neurolysis, Chronic Ulcer, Upper Extremity Ligament Injury
- Being tested
- 0.5% Hydrochloride Bupivacaine 20ml, 0.5% Hydrochloride Bupivacaine 10ml, Liposomal Bupivacaine 10mL
- Keywords
- Interscalene brachial plexus block, Liposomal Bupivacaine, Hemidiaphragmatic paralysis
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB | Experimental | ISBPB block group receiving combined administration of two drugs Receives: Drug: 0.5% Hydrochloride Bupivacaine 10ml; Drug: Liposomal Bupivacaine 10mL |
| 0.5% Hydrochloride Bupivacaine (20ml) for ISBPB | Active comparator | ISBPB block control group receiving single administration of a single drug Receives: Drug: 0.5% Hydrochloride Bupivacaine 20ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification the recovery time of diaphragmatic function after diaphragmatic paralysis caused by interscalene brachial plexus block
Measured: From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours)
Secondary outcomes (3)
Identification the recovery time of pulmonary function after diaphragmatic paralysis
Measured: 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
Measured: 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
Measured: Time Frame: From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start5 Dec 2025
- Primary completion20 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263295
- Sponsor's protocol ID
- ZJU_2025C116
- Status last verified
- Jul 2026
- First submitted
- 27 Sep 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided