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NCT01586806 · ClinicalTrials.gov registry record · Phase 4
Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
A Phase 4 study of Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 195
- Enrollment target
- 1
- Study location
NCT01586806: Completed Phase 4 study of Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block, sponsored by Hospital for Special Surgery, New York.
NCT01586806 is a Phase 4 study of Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 195 participants, below the 276-participant average among 11 other Anterior Cruciate Ligament Reconstruction trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01586806, a Phase 4 study of Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 195 participants
- Enrollment target
- 1
- Study location
Study Summary
For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia. Depending on the randomized treatment assignment, patients may receive one of the following: 1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone); 2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone; 3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone. Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.
Primary Outcome
After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.
Conditions Studied
Interventions
- DRUG Bupivacaine Only
- DRUG Bupivacaine with 1 mg of Dexamethasone
- DRUG Bupivacaine with 4 mg of Dexamethasone
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01586806 record still lists
NCT01586806 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, below the 276-participant average among 11 other Anterior Cruciate Ligament Reconstruction trials with a reported enrollment target (29% lower).
The record links to 2 conditions, with Anterior Cruciate Ligament Reconstruction appearing as the primary indexed condition, and to 3 interventions - of which Bupivacaine Only is the first listed.
NCT01586806 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01586806 about?
NCT01586806 is a clinical study titled "Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction". For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be r...
What is the current status of trial NCT01586806?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 195 participants. The study started on 2012-07. Estimated completion is 2014-12.
What conditions does trial NCT01586806 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Reconstruction, Regional Anesthesia, Saphenous Nerve Block.
What interventions are being tested in trial NCT01586806?
The interventions under investigation include: Bupivacaine Only (DRUG), Bupivacaine with 1 mg of Dexamethasone (DRUG), Bupivacaine with 4 mg of Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01586806?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01586806 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 NCT01586806's enrollment target sits among peer trials
195 5th of 11 higher than 7 of 11 other Anterior Cruciate Ligament Reconstruction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anterior Cruciate Ligament Reconstruction 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.
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