Clinical Observation of Bupivacaine Liposome for Lower Extremity Nerve Block (NCT07366905) | Clinical Trial Compass
CompletedPhase 2
Clinical Observation of Bupivacaine Liposome for Lower Extremity Nerve Block
China79 participantsStarted 2026-02-01
Plain-language summary
This prospective, sequential dose-finding clinical observational study aims to estimate the median effective concentration (EC50) and the 95% effective concentration (EC95) of liposomal bupivacaine for ultrasound-guided femoral nerve block. Sensory and motor block endpoints are evaluated separately at 30 minutes after block placement using a modified up-and-down (sequential allocation) design, with trial termination after eight reversal points.
Who can participate
Age range
18 Years – 85 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:
* Adults aged 18 to 85 years
* Scheduled for elective unilateral lower limb surgery
* Unilateral ultrasound-guided femoral nerve block clinically indicated as part of routine perioperative anesthesia and analgesia management
* Ability to clearly distinguish between the blocked (operated) limb and the contralateral (non-blocked) limb for sensory and pain assessments
* Ability to understand the study procedures and provide written informed consent
* Ability to cooperate with sensory and motor assessments, including visual analog scale (VAS) scoring and quadriceps muscle strength testing
Exclusion Criteria:
* Known allergy or hypersensitivity to bupivacaine, amide-type local anesthetics, or any component of liposomal bupivacaine
* Infection at or near the planned injection site
* Coagulopathy or clinically significant bleeding disorder, or anticoagulant/antiplatelet therapy incompatible with peripheral nerve block
* Pre-existing neurological deficits, neuropathy, or motor weakness affecting either lower limb that could interfere with sensory or motor assessments
* Severe hepatic dysfunction or other conditions that increase the risk of local anesthetic systemic toxicity
* Pregnancy or breastfeeding
* Emergency surgery
* Inability to complete study assessments or comply with study procedures
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
EC50 and EC95 for femoral nerve sensory block
Timeframe: 30 minutes after femoral nerve block placement
2
EC50 and EC95 for femoral nerve motor block
Timeframe: 30 minutes after femoral nerve block placement