NCT03968822

Intralipid® 20% for Reversal of Local Anesthetics

The Use of Intralipid® 20% Solution to Reverse the Anesthetic Effect of Local Anesthetics: a Proof of Concept Study in Volunteers

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study is to determine if a fat solution (Intralipid 20%) given intravenously can reverse the effects of local anesthetics. Local anesthetics are drugs that cause numbness when they are injected into different parts of the body. Local anesthetics are important drugs because they allow doctors to perform surgeries and other procedures on patients; however, there are certain instances where it would be helpful to reverse the effects of local anesthetics and reduce the amount of time that they produce numbness. 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

Type	Name	Description
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

Timeline

• Start date: 2019-07-26
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2019-05-30
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study