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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diaphragmatic Function After Interscalene Brachial Plexus Block With Liposomal Bupivacaine: A Cohort Study
- ClinicalTrials.gov ID
- NCT07263295
- Acronym / sponsor ID
- ZJU_2025C116
- Conditions
- Diaphragmatic Function, Metacarpal Fracture, Radius Fracture, Peripheral Nerve Neurolysis, Chronic Ulcer, Upper Extremity Ligament Injury
- Keywords
- Interscalene brachial plexus block, Liposomal Bupivacaine, Hemidiaphragmatic paralysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB | Experimental | Drug: 0.5% Hydrochloride Bupivacaine 10ml, Drug: Liposomal Bupivacaine 10mLISBPB block group receiving combined administration of two drugs |
| 0.5% Hydrochloride Bupivacaine (20ml) for ISBPB | Active comparator | Drug: 0.5% Hydrochloride Bupivacaine 20mlISBPB block control group receiving single administration of a single drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing upper limb surgery scheduled for interscalene brachial plexus block
- Aged ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% Hydrochloride Bupivacaine 20ml0.5% Hydrochloride Bupivacaine 20ml for ISBPB | Drug | 0.5% Hydrochloride Bupivacaine (20ml) for ISBPB |
| 0.5% Hydrochloride Bupivacaine 10ml0.5% Hydrochloride Bupivacaine 10ml for ISBPB | Drug | Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB |
| Liposomal Bupivacaine 10mLLiposomal Bupivacaine 10mL for ISBPB | Drug | Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB |
Primary outcome
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)
3 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diaphragmatic Function
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Not yet recruiting
Abdominal Air-Pressure Resistance Versus Abdominal Weight Training for Improving Diaphragm Function in Healthy Young Adults
Diaphragm Thickness, Dyspnoea
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
Not yet recruitingObservational study
Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty
Abdominoplasty, Diaphragm
Recruiting
Diaphragmatic Facilitation and Upper Extremity Performance in Volleyball Players
Volleyball Players
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.