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Lidocaine vs Nerve Block for Knee Replacement Surgery (ACBSL Trial)

Phase 4

Recruiting

Led By Vendhan Ramanujam, M.D.

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

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

Must have

ASA PS 1-3 patients undergoing primary, unilateral total knee arthroplasty

Be older than 18 years old

Must not have

Coagulopathy

Pre-existing neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether lidocaine or a nerve block can help with pain relief after knee surgery.

Who is the study for?

This trial is for adults in good to moderate health (ASA PS 1-3) who are having their first knee replacement surgery on one knee. It's not for those with severe systemic disease, nerve issues, blood clotting problems, long-term opioid use, infections at the surgery site, allergies to lidocaine, certain heart conditions, a stroke history or liver disease.

What is being tested?

The study compares two types of anesthesia techniques in patients getting knee replacements: one group receives Lidocaine through an IV and the other gets a local anesthesia block guided by ultrasound near the thigh nerves.

What are the potential side effects?

Lidocaine may cause side effects like dizziness, sleepiness, changes in vision or hearing; rarely it can affect heart rhythm or cause seizures if blood levels get too high. Local blocks might lead to numbness or weakness in the leg temporarily.

Eligibility Criteria

Inclusion Criteria

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

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I am having my first knee replacement and my health is rated fair to poor.

Exclusion Criteria

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

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I have a blood clotting disorder.

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I have nerve damage.

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I am currently using lidocaine patches.

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My health is severely limited by my illness.

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I have had a stroke or mini-stroke in the past.

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I have an infection at the site.

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I have a liver condition.

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I have a severe heart rhythm problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery. for reporting.