Clinical trial NCT03968822: Intralipid® 20% for Reversal of Local Anesthetics
Official title: The Use of Intralipid® 20% Solution to Reverse the Anesthetic Effect of Local Anesthetics: a Proof of Concept Study in Volunteers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Anesthesia, Local
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to complete normal sensation after lidocaine 1%
timeFrame: up to 24 hours
measure: Time to complete normal sensation after lidocaine 2%
timeFrame: up to 24 hours
measure: Time to complete normal sensation after Bupivacaine 0.5%
timeFrame: up to 24 hours
measure: Time to complete normal sensation after Bupivacaine 0.25%
timeFrame: up to 24 hours
Secondary outcomes:
measure: Time to normal cold swab sensation after lidocaine 1%
timeFrame: up to 24 hours
measure: Time to normal pinprick sensation after lidocaine 1%
timeFrame: up to 24 hours
measure: Time to normal cold swab sensation after lidocaine 2%
timeFrame: up to 24 hours
measure: Time to normal pin prick sensation after lidocaine 2%
timeFrame: up to 24 hours
measure: Time to normal pinprick sensation after Bupivacaine 0.5%
timeFrame: up to 24 hours
measure: Time to normal cold swab sensation after Bupivacaine 0.5%
timeFrame: up to 24 hours
measure: Time to normal cold swab sensation after Bupivacaine 0.25%
timeFrame: up to 24 hours
measure: Time to normal pinprick sensation after Bupivacaine 0.25%
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital of Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Stavros Memtsoudis, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: