Intralipid® 20% for Reversal of Local Anesthetics
NCT03968822 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-12-08
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.
Conditions
- Anesthesia, Local
Interventions
- DRUG
-
Lidocaine 2%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
- DRUG
-
Lidocaine 1%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
- DRUG
-
Bupivacaine 0.25%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
- DRUG
-
Bupivacaine 0.5%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
- DRUG
-
Intralipid, 20% Intravenous
a 250ml bag administered intravenously
- OTHER
-
Saline intravenously
a 250ml bag administered intravenously
- OTHER
-
Saline
3 mL of test solution to a skin area on the thigh, 2cm in diameter
Sponsors & Collaborators
-
Hospital for Special Surgery, New York
lead OTHER
Principal Investigators
-
Stavros Memtsoudis, MD/PhD · Hospital for Special Surgery, New York
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-07-26
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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