Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene… (NCT06972680) | Clinical Trial Compass
By InvitationNot Applicable
Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial
China60 participantsStarted 2025-05-01
Plain-language summary
This single-center, prospective, single-arm, Bayesian phase I/II clinical trial evaluates the incidence of HDP following ISB in shoulder arthroscopy and determines the optimal volume of a single injection of liposomal bupivacaine.
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 aged 18 years and above;
* ASA classification I-III;
* Undergoing arthroscopic rotator cuff repair, capsular tightening, acromioplasty, synovectomy,.
Exclusion Criteria:
* History of pulmonary disease;
* Abnormal coagulation function or coagulation disorders;
* History of local anesthetic allergy;
* Infection, lesion, or history of cervical disease at the block site;
* Pregnancy;
* Refusal to participate in the study or inability to communicate;
* Long-term use of opioids;
* Body mass index \>35 kg/m2;
* History of nerve injury, paralysis, or paresis.
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
Hemidiaphragmatic paresis incidence rate(Phase Ⅰ)
Timeframe: Perioperative
2
Success rate of interscalene brachial plexus block (Phase II)