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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

Must not have

Use of drugs affecting the sensorium (including opioids, benzodiazepines, antipsychotics, gabapentinoids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication that affects my awareness or consciousness.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: 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 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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine 2%

2015

Completed Phase 4

~190

Lidocaine 1%

2013

Completed Phase 3

~490