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NCT01333943 · ClinicalTrials.gov registry record · NA
Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
A NA study of Total Knee Arthroplasty, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT01333943: Completed NA study of Total Knee Arthroplasty, sponsored by Hospital for Special Surgery, New York.
NCT01333943 is a NA study of Total Knee Arthroplasty that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 94 participants, below the 292-participant average among 29 other Total Knee Arthroplasty trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01333943, a NA study of Total Knee Arthroplasty, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study Summary
Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the knee joint. The femoral nerve also provides movement and sensation. While this regional anesthetic technique offers significant postoperative pain relief, it is possible that it may cause muscle weakness and increase patients' recovery time. Hence there is a need for an alternative technique, one that may help minimize postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps muscle. The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized that by "blocking" or anesthetizing the saphenous nerve with local anesthetic closer to where it branches off, the area around and below the knee will feel numb. Yet unlike with the FNB, the quadriceps muscle itself will still be able to function. Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia administration, and on postoperative days 1 and 2. It is hypothesized that patients who receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.
Primary Outcome
Measurements were made by a handheld dynamometer while patients perform isometric exercises. Results are presented in kilogram-force (kgF) units. One kgF is equal to 9.80665 N.
Conditions Studied
Interventions
- PROCEDURE Study Group: Experimental
- PROCEDURE Control Group
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-11 |
| Phase | NA |
What the finished NCT01333943 record still lists
NCT01333943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 292-participant average among 29 other Total Knee Arthroplasty trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Total Knee Arthroplasty appearing as the primary indexed condition, and to 2 interventions - of which Study Group: Experimental is the first listed.
NCT01333943 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01333943 about?
NCT01333943 is a clinical study titled "Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty". Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the k...
What is the current status of trial NCT01333943?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2011-03. Estimated completion is 2011-11.
What conditions does trial NCT01333943 study?
This clinical trial studies the following conditions: Total Knee Arthroplasty.
What interventions are being tested in trial NCT01333943?
The interventions under investigation include: Study Group: Experimental (PROCEDURE), Control Group (PROCEDURE).
Who is sponsoring clinical trial NCT01333943?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01333943 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01333943's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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