Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:33 PM
Study NCT ID:
NCT07366905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Observation of Bupivacaine Liposome for Lower Extremity Nerve Block
Sponsor:
Hainan Medical College
Organization:
Study Overview
Official Title:
Clinical Observation of Bupivacaine Liposome for Lower Extremity Femoral Nerve Block
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This prospective clinical observational, sequential dose-finding study is designed to determine the effective concentrations of liposomal bupivacaine for ultrasound-guided femoral nerve block in patients undergoing lower limb surgery or related procedures.
All patients receive ultrasound-guided femoral nerve block performed by an experienced anesthesiologist using a standardized technique. A fixed injection volume of liposomal bupivacaine is administered, while the drug concentration is adjusted according to a modified up-and-down sequential method. The concentration for each subsequent participant is determined based on the response of the preceding participant. Following a positive response, the concentration is decreased; following a negative response, the concentration is increased by a pre-specified step size. The study is terminated after eight reversal points (crossovers) are observed.
To independently characterize sensory and motor block dose-response relationships, participants are allocated into two endpoint-specific observation groups:
Sensory block group
Sensory function in the femoral nerve distribution is assessed 30 minutes after block placement using standardized sensory testing. Complete loss of sensation at 30 minutes is defined as a positive response, while preserved sensation is defined as a negative response.
Motor block group
Motor function of the quadriceps muscle is evaluated 30 minutes after block placement using a standardized motor strength assessment. Complete loss of quadriceps muscle strength or paralysis at 30 minutes is defined as a positive response, while preservation of motor function is defined as a negative response.
The primary objective of this study is to estimate the EC50 and EC95 of liposomal bupivacaine for:
femoral nerve sensory blockade, and
femoral nerve motor blockade,
based on sequential allocation data and appropriate dose-response modeling.
Secondary objectives include describing the differential sensory-motor block profile of liposomal bupivacaine and evaluating its clinical feasibility and safety for femoral nerve block applications. All patients are monitored for block-related adverse events, including signs of local anesthetic systemic toxicity, nerve injury, and other complications throughout the perioperative period.
All patients receive ultrasound-guided femoral nerve block performed by an experienced anesthesiologist using a standardized technique. A fixed injection volume of liposomal bupivacaine is administered, while the drug concentration is adjusted according to a modified up-and-down sequential method. The concentration for each subsequent participant is determined based on the response of the preceding participant. Following a positive response, the concentration is decreased; following a negative response, the concentration is increased by a pre-specified step size. The study is terminated after eight reversal points (crossovers) are observed.
To independently characterize sensory and motor block dose-response relationships, participants are allocated into two endpoint-specific observation groups:
Sensory block group
Sensory function in the femoral nerve distribution is assessed 30 minutes after block placement using standardized sensory testing. Complete loss of sensation at 30 minutes is defined as a positive response, while preserved sensation is defined as a negative response.
Motor block group
Motor function of the quadriceps muscle is evaluated 30 minutes after block placement using a standardized motor strength assessment. Complete loss of quadriceps muscle strength or paralysis at 30 minutes is defined as a positive response, while preservation of motor function is defined as a negative response.
The primary objective of this study is to estimate the EC50 and EC95 of liposomal bupivacaine for:
femoral nerve sensory blockade, and
femoral nerve motor blockade,
based on sequential allocation data and appropriate dose-response modeling.
Secondary objectives include describing the differential sensory-motor block profile of liposomal bupivacaine and evaluating its clinical feasibility and safety for femoral nerve block applications. All patients are monitored for block-related adverse events, including signs of local anesthetic systemic toxicity, nerve injury, and other complications throughout the perioperative period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| No.823RC592 | OTHER_GRANT | Hainan Provincial Natural Science Foundation of China | View |