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NCT03303794 · ClinicalTrials.gov registry record · Phase 3
0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka
A Phase 3 study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
NCT03303794: Clinical Trial Phase 3 study, sponsored by Montefiore Medical Center.
NCT03303794 is a Phase 3 study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03303794, a Phase 3 study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
Study Summary
Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.
Primary Outcome
AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.
Interventions
- DRUG Exparel
- DRUG 0.25% bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2017-10-25 |
| Est. Completion | 2018-06-27 |
| Phase | Phase 3 |
Why NCT03303794 stopped before completion
NCT03303794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Exparel is the first listed.
NCT03303794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03303794 about?
NCT03303794 is a clinical study titled "0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka". Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the r...
What is the current status of trial NCT03303794?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2017-10-25. Estimated completion is 2018-06-27.
What interventions are being tested in trial NCT03303794?
The interventions under investigation include: Exparel (DRUG), 0.25% bupivacaine (DRUG).
Who is sponsoring clinical trial NCT03303794?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03303794's enrollment target sits among peer trials
25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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