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NCT03968822 · ClinicalTrials.gov registry record · Phase 4
Intralipid® 20% for Reversal of Local Anesthetics
A Phase 4 study of Anesthesia, Local, sponsored by Hospital for Special Surgery, New York.
- Active
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03968822: Active Phase 4 study of Anesthesia, Local, sponsored by Hospital for Special Surgery, New York.
NCT03968822 is a Phase 4 study of Anesthesia, Local that is active but no longer recruiting, run by Hospital for Special Surgery, New York. The registered enrollment target is 18 participants, below the 82-participant average among 18 other Anesthesia, Local trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03968822, a Phase 4 study of Anesthesia, Local, is active but no longer recruiting, sponsored by Hospital for Special Surgery, New York.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
In order to determine if Intralipid 20% can be used to reverse the effects of local anesthetics, the investigators will recruit 18 volunteers who will be asked to come to HSS for two study visits. Small amounts of local anesthetics will be injected into the volunteers' thighs during both visits. During one visit volunteers will receive Intralipid 20% and during the other visit they will receive a saline solution. The study team will measure how quickly normal sensation returns to the thighs when the volunteers get Intralipid 20% compared to saline.
Primary Outcome
The time (measured in minutes) when the participant reports normal sensation of both cold swab and pinprick at the injection site of lidocaine 1%. Although measured for each individual participant, the average time across all participants is reported.
Conditions Studied
Interventions
- DRUG Lidocaine 2%
- DRUG Lidocaine 1%
- DRUG Bupivacaine 0.25%
- DRUG Bupivacaine 0.5%
- DRUG Intralipid, 20% Intravenous
Study Locations (1)
New York
- Hospital of Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-07-26 |
| Est. Completion | 2026-10 |
| Phase | Phase 4 |
What the registry record for NCT03968822 still lists
NCT03968822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 82-participant average among 18 other Anesthesia, Local trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Anesthesia, Local appearing as the primary indexed condition, and to 5 interventions - of which Lidocaine 2% is the first listed.
NCT03968822 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03968822 about?
NCT03968822 is a clinical study titled "Intralipid® 20% for Reversal of Local Anesthetics". In order to determine if Intralipid 20% can be used to reverse the effects of local anesthetics, the investigators will recruit 18 volunteers who will be asked to come to HSS for two study visits. Small amounts of local anesthetics will be injected into the volunteers' thighs during both visits. Dur...
What is the current status of trial NCT03968822?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2019-07-26. Estimated completion is 2026-10.
What conditions does trial NCT03968822 study?
This clinical trial studies the following conditions: Anesthesia, Local.
What interventions are being tested in trial NCT03968822?
The interventions under investigation include: Lidocaine 2% (DRUG), Lidocaine 1% (DRUG), Bupivacaine 0.25% (DRUG), Bupivacaine 0.5% (DRUG), Intralipid, 20% Intravenous (DRUG).
Who is sponsoring clinical trial NCT03968822?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03968822 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03968822's enrollment target sits among peer trials
18 19th of 18 the lowest of 18 other Anesthesia, Local trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anesthesia, Local 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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