Intralipid® 20% for Reversal of Local Anesthetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-26

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Patients will be blinded to which treatment they are receiving both times they come in for the study.

Study Groups

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Intralipid 20% IV Bolus

This is 1 out of the 2 study visits. The patient will receive 6 injections (3 in each thigh). The 6 injections are:

1. lidocaine 1%
2. lidocaine 2%
3. bupivacaine 0.5%
4. bupivacaine 0.25%
5. saline
6. no injection

Each test solution will be injected over 5 seconds through a 27G needle and tuberculin syringe at a 30 degree angle.

The patient will also receive an intravenous bolus in the arm of Intralipid 20%.

Participant will be blindfolded for these activities so they will not know what they received during the visit.

Group Type EXPERIMENTAL

Lidocaine 2%

Intervention Type DRUG

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Lidocaine 1%

Intervention Type DRUG

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Bupivacaine 0.25%

Intervention Type DRUG

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Bupivacaine 0.5%

Intervention Type DRUG

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Intralipid, 20% Intravenous

Intervention Type DRUG

a 250ml bag administered intravenously

Saline

Intervention Type OTHER

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Saline

This is 2 out of the 2 study visits. The patient will receive 6 injections (3 in each thigh). The 6 injections are:

1. lidocaine 1%
2. lidocaine 2%
3. bupivacaine 0.5%
4. bupivacaine 0.25%
5. saline
6. no injection

Each test solution will be injected over 5 seconds through a 27G needle and tuberculin syringe at a 30 degree angle.

The patient will also receive an intravenous bolus in the arm of Saline.

Participant will be blindfolded for these activities so they will not know what they received during the visit.

Group Type PLACEBO_COMPARATOR

Lidocaine 2%

Intervention Type DRUG

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Lidocaine 1%

Intervention Type DRUG

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Bupivacaine 0.25%

Intervention Type DRUG

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Bupivacaine 0.5%

Intervention Type DRUG

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Saline intravenously

Intervention Type OTHER

a 250ml bag administered intravenously

Saline

Intervention Type OTHER

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Interventions

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Lidocaine 2%

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Intervention Type DRUG

Lidocaine 1%

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Intervention Type DRUG

Bupivacaine 0.25%

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Intervention Type DRUG

Bupivacaine 0.5%

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Intervention Type DRUG

Intralipid, 20% Intravenous

a 250ml bag administered intravenously

Intervention Type DRUG

Saline intravenously

a 250ml bag administered intravenously

Intervention Type OTHER

Saline

3 mL of test solution to a skin area on the thigh, 2cm in diameter

Intervention Type OTHER

Other Intervention Names

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Lidocaine Viscous Lidoderm Recticare Lidocaine Viscous Lidoderm Recticare Marcaine Sensorcaine Marcaine Sensorcaine i.v. fat emulsion salt salt

Eligibility Criteria

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Inclusion Criteria

* English speaking
* BMI 18-25, with body weight between 50-100kg

Exclusion Criteria

* ASA III or higher
* Pregnant Women
* Allergy to study medications (lidocaine, bupivacaine, soybeans, eggs)
* Use of drugs affecting the sensorium (including opioids, benzodiazepines, antipsychotics, gabapentinoids)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes