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Clinical Observation of Bupivacaine Liposome for Lower Extremity Femoral Nerve Block
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.
Details
| Lead sponsor | Hainan Medical College |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 79 |
| Start date | 2026-02-01 |
| Completion | 2026-04-01 |
Conditions
- Patients Eligible for Elective Lower Extremity Femoral Nerve Surgery
- Knee Arthroscopic Surgery
Interventions
- Liposomal bupivacaine, 266mg
Primary outcomes
- EC50 and EC95 for femoral nerve sensory block — 30 minutes after femoral nerve block placement
The median effective concentration (EC50) and the 95% effective concentration (EC95) of liposomal bupivacaine for ultrasound-guided femoral nerve sensory blockade are estimated using a modified up-and-down sequential dose-finding design. Sensory block is assessed 30 minutes after block placement in the femoral nerve distribution on the blocked side, including the anterior thigh (anterior femoral cutaneous nerve territory) and the medial aspect of the lower leg (saphenous nerve territory). Sensory testing is performed using pinprick testing and/or cold stimulation with an ether-soaked cotton swab, with the contralateral non-blocked limb used as an internal control. Sensory block is graded as follows: 0 = no block (sensation identical to the non-blocked limb); 1 = partial block (reduced sensation); 2 = complete block (absence of pain sensation). A positive sensory response is defined as a sensory block score of 2. - EC50 and EC95 for femoral nerve motor block — 30 minutes after femoral nerve block placement
The median effective concentration (EC50) and the 95% effective concentration (EC95) of liposomal bupivacaine for ultrasound-guided femoral nerve motor blockade, estimated using a modified up-and-down sequential dose-finding design. Motor function is evaluated immediately by assessing quadriceps muscle strength. Patients are instructed to perform a straight leg raise in the supine position or actively extend the knee. Muscle strength is graded using the Medical Research Council (MRC) scale (0-5). The successful (positive) quadriceps motor block is defined as a decrease of ≥1 grade in the muscle strength of the quadriceps compared with that before the block.
Countries
China