← Back to Search

Intralipid® 20% for Local Anesthetic Reversal

Phase 4

Recruiting

Led By Stavros Memtsoudis, MD/PhD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Study Summary

This trial will test whether Intralipid 20% can help to offset the effects of local anesthetics.

Who is the study for?

This trial is for healthy English-speaking volunteers with a BMI of 18-25 and body weight between 50-100kg. It's not suitable for pregnant women, those with significant medical conditions (ASA III or higher), allergies to lidocaine, bupivacaine, soybeans, eggs, or those using drugs that affect the senses like opioids.Check my eligibility

What is being tested?

The study tests if Intralipid® 20%, an intravenous fat emulsion, can reverse numbness from local anesthetics faster than saline solution. Volunteers will receive small doses of local anesthetics in their thighs and then either Intralipid® or saline to compare recovery times.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain or swelling, changes in sensation beyond the intended numbness from the anesthetic agents used (lidocaine and bupivacaine), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 18-25 and I weigh between 50-100kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to complete normal sensation after Bupivacaine 0.25%

Time to complete normal sensation after Bupivacaine 0.5%

Time to complete normal sensation after lidocaine 1%

+1 more

Secondary outcome measures

Time to normal cold swab sensation after Bupivacaine 0.25%

Time to normal cold swab sensation after Bupivacaine 0.5%

Time to normal cold swab sensation after lidocaine 1%

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intralipid 20% IV BolusExperimental Treatment6 Interventions

This is 1 out of the 2 study visits. The patient will receive 6 injections (3 in each thigh). The 6 injections are: lidocaine 1% lidocaine 2% bupivacaine 0.5% bupivacaine 0.25% saline 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 II: SalinePlacebo Group6 Interventions

This is 2 out of the 2 study visits. The patient will receive 6 injections (3 in each thigh). The 6 injections are: lidocaine 1% lidocaine 2% bupivacaine 0.5% bupivacaine 0.25% saline 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine 0.25%

2016

Completed Phase 4

~950

Bupivacaine 0.5%

2015

Completed Phase 4

~350

Lidocaine 2%

2015

Completed Phase 4

~190

Lidocaine 1%

2013

Completed Phase 3

~490

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,312 Total Patients Enrolled

Stavros Memtsoudis, MD/PhDPrincipal InvestigatorHospital for Special Surgery, New York

1 Previous Clinical Trials

64 Total Patients Enrolled

Media Library

Intralipid 20% IV Bolus Clinical Trial Eligibility Overview. Trial Name: NCT03968822 — Phase 4

Local Anesthesia Research Study Groups: Intralipid 20% IV Bolus, Saline

Local Anesthesia Clinical Trial 2023: Intralipid 20% IV Bolus Highlights & Side Effects. Trial Name: NCT03968822 — Phase 4

Intralipid 20% IV Bolus 2023 Treatment Timeline for Medical Study. Trial Name: NCT03968822 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this research still ongoing?

"This clinical study is not currently enrolling participants. It was initially posted on July 26th, 2019 and lastly modified on December 1st 2022. If you are looking for alternative trials, there are 43 studies actively recruiting patients related to anaesthesia, local as well as 230 studies with respect to Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable solution, saline or no injection -- followed by IL 20 % IV Bolus searching for volunteers."

Answered by AI

Are there any records of patients being administered a combination of Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable solution, saline and IL 20% IV Bolus in past clinical trials?

"Currently, there are 230 trials in progress researching Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable solution, saline and no injection -- Followed by IL 20% IV Bolus of which 51 have entered Phase 3 testing. The primary site for these studies is Germantown Tennessee however 1258 other locations also run investigations into this medication's efficacy."

Answered by AI

How many participants are allowed to join this clinical investigation?

"At this time, no new enrolments are being accepted for the clinical trial. It was initially advertised on July 26th 2019 and last updated December 1st 2022. If you seek alternative studies, there are presently 43 trials recruiting patients with anesthesia local; as well as 230 accepting candidates for lidocaine 2%, lidocaine 1%, bupivacaine 0.25% and 0.5% injectable solution; saline or no injection followed by IL 20% IV Bolus infusion treatment"

Answered by AI

What medical conditions are Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable solution, saline and no injection -- Followed by IL 20% IV Bolus regularly used to treat?

"Treatment of minor burns, lupus erythematosus cell and ulcerative colitis can be facilitated with the administration of Lidocaine 2% Injectable Solution, Lidocaine 1% injectable solution, Bupivacaine 0.25%, Bupivacaine 0.5%, saline or no injection followed by an Intravenous Bolus containing 20 percent lidocane; it also may prove beneficial after transplantation operations."

Answered by AI

What risk factors are associated with the administration of Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable solution, saline and no injection followed by IL 20% IV Bolus to patients?

"The safety of Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable solution, saline, no injection -- Followed by IL 20% IV Bolus has been certified due to its Phase 4 status and was thus given the highest score on our scale at 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intralipid® 20% for Reversal of Local Anesthetics

2019. "Intralipid® 20% for Reversal of Local Anesthetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03968822.

All > Anesthesia > Exparel