Intralipid® 20% for Reversal of Local Anesthetics

NCT03968822 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-08

No results posted yet for this 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.

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968822 on ClinicalTrials.gov