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NCT01349140 · ClinicalTrials.gov registry record · Phase 1
EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks
A Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01349140: Completed Phase 1 study, sponsored by University of California, San Diego.
NCT01349140 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349140, a Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
Primary Outcome
A dynamometer was used to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90°. The dynamometer was placed on the anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the ipsilateral quadriceps femoris, maintain this effort for 5 seconds, and then relax. The measurements immediately before study drug admini
Interventions
- DRUG SKY0402
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01349140 record still lists
NCT01349140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which SKY0402 is the first listed.
NCT01349140 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01349140 about?
NCT01349140 is a clinical study titled "EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks". EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duratio...
What is the current status of trial NCT01349140?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-02. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01349140?
The interventions under investigation include: SKY0402 (DRUG).
Who is sponsoring clinical trial NCT01349140?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01349140's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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