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NCT01683071 · ClinicalTrials.gov registry record · Phase 2
Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty
A Phase 2 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 297
- Enrollment target
NCT01683071: Completed Phase 2 study, sponsored by Pacira Pharmaceuticals.
NCT01683071 is a Phase 2 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 297 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01683071, a Phase 2 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 297 participants
- Enrollment target
Study Summary
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be tested in Part 2. Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the analgesic effect of single injection femoral nerve block of a single dose level of liposome bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).
Primary Outcome
AUC of NRS-R pain intensity scores through 72 hours. Pain intensity scores were measured on an 11-point NRS (0=no pain and 10=worst possible pain)
Interventions
- DRUG Placebo
- DRUG EXPAREL 67 mg
- DRUG EXPAREL 133 mg
- DRUG EXPAREL 266 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01683071 record still lists
NCT01683071 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01683071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01683071 about?
NCT01683071 is a clinical study titled "Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty". The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic...
What is the current status of trial NCT01683071?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 297 participants. The study started on 2012-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01683071?
The interventions under investigation include: Placebo (DRUG), EXPAREL 67 mg (DRUG), EXPAREL 133 mg (DRUG), EXPAREL 266 mg (DRUG).
Who is sponsoring clinical trial NCT01683071?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01683071's enrollment target sits among peer trials
297 188th of 2000 higher than 1,812 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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