Clinical trial
The Use of Intralipid® 20% Solution to Reverse the Anesthetic Effect of Local Anesthetics: a Proof of Concept Study in Volunteers
Name
2018-2039
Description
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.
Trial arms
Trial start
2019-07-26
Estimated PCD
2024-10-01
Trial end
2025-10-01
Status
Recruiting
Phase
Early phase I
Treatment
Lidocaine 2%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
Arms:
Intralipid 20% IV Bolus, Saline
Other names:
Lidocaine Viscous, Lidoderm, Recticare
Lidocaine 1%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
Arms:
Intralipid 20% IV Bolus, Saline
Other names:
Lidocaine Viscous, Lidoderm, Recticare
Bupivacaine 0.25%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
Arms:
Intralipid 20% IV Bolus, Saline
Other names:
Marcaine, Sensorcaine
Bupivacaine 0.5%
3 mL of test solution to a skin area on the thigh, 2cm in diameter
Arms:
Intralipid 20% IV Bolus, Saline
Other names:
Marcaine, Sensorcaine
Intralipid, 20% Intravenous
a 250ml bag administered intravenously
Arms:
Intralipid 20% IV Bolus
Other names:
i.v. fat emulsion
Saline intravenously
a 250ml bag administered intravenously
Arms:
Saline
Other names:
salt
Saline
3 mL of test solution to a skin area on the thigh, 2cm in diameter
Arms:
Intralipid 20% IV Bolus, Saline
Other names:
salt
Size
18
Primary endpoint
Time to complete normal sensation after lidocaine 1%
up to 24 hours
Time to complete normal sensation after lidocaine 2%
up to 24 hours
Time to complete normal sensation after Bupivacaine 0.5%
up to 24 hours
Time to complete normal sensation after Bupivacaine 0.25%
up to 24 hours
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients will be blinded to which treatment they are receiving both times they come in for the study.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}
Updated at
2024-03-06
1 organization
4 products
2 indications
Organization
Hospital for Special SurgeryProduct
LidocaineIndication
AnesthesiaIndication
LocalProduct
BupivacaineProduct
Bupivacaine 0.5%Product
Intralipid