Intralipid® 20% for Reversal of Local Anesthetics

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968822
• Other study ID #: 2018-2039
• Status: Recruiting
• Phase: Phase 4
• Start date: July 26, 2019
• Est. completion date: October 2025

Study information

• Verified date: March 2024
• Source: Hospital for Special Surgery, New York
• Contact: Marko Popovic, BS
• Phone: 646-797-8948
• Email: popovicm[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• Lidocaine 2%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
• Lidocaine 1%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
• Bupivacaine 0.25%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
• Bupivacaine 0.5%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
• Intralipid, 20% Intravenous
a 250ml bag administered intravenously

Other:
• Saline intravenously
a 250ml bag administered intravenously
• Saline
3 mL of test solution to a skin area on the thigh, 2cm in diameter

Locations

Country	Name	City	State
United States	Hospital of Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete normal sensation after lidocaine 1%	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.	up to 24 hours
Primary	Time to complete normal sensation after lidocaine 2%	The time (measured in minutes) when the participant reports normal sensation of both cold swab and pinprick at the injection site of lidocaine 2%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Primary	Time to complete normal sensation after Bupivacaine 0.5%	The time (measured in minutes) when the participant reports normal sensation of both cold swab and pinprick at the injection site of Bupivacaine 0.5%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Primary	Time to complete normal sensation after Bupivacaine 0.25%	The time (measured in minutes) when the participant reports normal sensation of both cold swab and pinprick at the injection site of Bupivacaine 0.25%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Secondary	Time to normal cold swab sensation after lidocaine 1%	The time (measured in minutes) when the participant reports normal sensation of cold swab at the injection site of lidocaine 1%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Secondary	Time to normal pinprick sensation after lidocaine 1%	The time (measured in minutes) when the participant reports normal sensation of pinprick at the injection site of lidocaine 1%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Secondary	Time to normal cold swab sensation after lidocaine 2%	The time (measured in minutes) when the participant reports normal sensation of cold swab at the injection site of lidocaine 2%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Secondary	Time to normal pin prick sensation after lidocaine 2%	The time (measured in minutes) when the participant reports normal sensation of pinprick at the injection site of lidocaine 2%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Secondary	Time to normal pinprick sensation after Bupivacaine 0.5%	The time (measured in minutes) when the participant reports normal sensation of pinprick at the injection site of Bupivacaine 0.5%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Secondary	Time to normal cold swab sensation after Bupivacaine 0.5%	The time (measured in minutes) when the participant reports normal sensation of cold swab at the injection site of Bupivacaine 0.5%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Secondary	Time to normal cold swab sensation after Bupivacaine 0.25%	The time (measured in minutes) when the participant reports normal sensation of cold swab at the injection site of Bupivacaine 0.25%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours
Secondary	Time to normal pinprick sensation after Bupivacaine 0.25%	The time (measured in minutes) when the participant reports normal sensation of pinprick at the injection site of Bupivacaine 0.25%.; Although measured for each individual participant, the average time across all participants is reported.	up to 24 hours