Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine (NCT07263295) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
China120 participantsStarted 2025-12-05
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification the recovery time of diaphragmatic function after diaphragmatic paralysis caused by interscalene brachial plexus block
Timeframe: From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours)