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NCT00923598 · ClinicalTrials.gov registry record · Phase 4
Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT00923598: Completed Phase 4 study, sponsored by University of California, San Diego.
NCT00923598 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 48 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923598, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.
Primary Outcome
A device was used called a dynamometer to measure the force during maximum voluntary isometric contraction. The dynamometer was placed on ipsilateral 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 quadriceps, maintain this effort for 5 seconds, and then relax.
Interventions
- DRUG 0.1% and 0.4% perineural ropivicaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
What the finished NCT00923598 record still lists
NCT00923598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which 0.1% and 0.4% perineural ropivicaine is the first listed.
NCT00923598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00923598 about?
NCT00923598 is a clinical study titled "Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks". This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will re...
What is the current status of trial NCT00923598?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2009-06. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00923598?
The interventions under investigation include: 0.1% and 0.4% perineural ropivicaine (DRUG).
Who is sponsoring clinical trial NCT00923598?
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 NCT00923598's enrollment target sits among peer trials
48 1331st of 2000 higher than 653 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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