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NCT01335542 · ClinicalTrials.gov registry record · Phase 4
Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 91
- Enrollment target
NCT01335542: Completed Phase 4 study, sponsored by Hospital for Special Surgery, New York.
NCT01335542 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 91 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335542, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 91 participants
- Enrollment target
Study Summary
There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.
Primary Outcome
The primary outcome is time until a patient is "ready for discharge." Discharge criteria are: * PCA (if present) has been discontinued * Not experiencing moderate or severe nausea (within last 4 hours). * Solid food diet * Able to urinate (Foley catheter removed) * Pain: NRS \<4. * Surgical wound dry * No acute medical problems * Physical Therapy Criteria * Independently transfer from supine to sit, from sitting to standing * Ambulate 40 ft. without assistance * Extension range of motion
Interventions
- PROCEDURE Peri-Articular Injection
- PROCEDURE Epidural Pathway (PCEA+FNB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-09 |
| Phase | Phase 4 |
What the finished NCT01335542 record still lists
NCT01335542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Peri-Articular Injection is the first listed.
NCT01335542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01335542 about?
NCT01335542 is a clinical study titled "Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade". There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a p...
What is the current status of trial NCT01335542?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 91 participants. The study started on 2010-03. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01335542?
The interventions under investigation include: Peri-Articular Injection (PROCEDURE), Epidural Pathway (PCEA+FNB) (PROCEDURE).
Who is sponsoring clinical trial NCT01335542?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01335542's enrollment target sits among peer trials
91 884th of 2000 higher than 1,115 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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