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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

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

ACBSL Trial 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.Check my eligibility

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.See study design

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.

ACBSL Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

ACBSL Trial 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.

Treatment Details

Study Objectives

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

Primary outcome measures

Postoperative opioid consumption

Secondary outcome measures

Pain Scores

Quality of Recovery

ACBSL Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Ultrasound-guided adductor canal block with local anestheticActive Control1 Intervention

Single shot Ultrasound-guided adductor canal block with 0.5% ropivacaine 30 ml

Group II: Ultrasound-guided adductor canal block with salinePlacebo Group1 Intervention

Single shot Ultrasound-guided adductor canal block with 30 mL of normal saline (Sodium chloride)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,887 Total Patients Enrolled

Vendhan Ramanujam, M.D.Principal InvestigatorRhode Island Hospital, Brown University

Alexander Cohen, M.D.Principal InvestigatorRhode Island Hospital, Brown University

1 Previous Clinical Trials

174 Total Patients Enrolled

Frequently Asked Questions

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

What types of pain symptoms can be addressed with Ultrasound-guided adductor canal block and local anesthetic?

"Ultrasound-guided adductor canal block with local anesthetic is a common procedure for managing intra ocular pressure (iop). It may also be used clinically to ameliorate nasal irritation, increased renal excretion of toxic substances, and sciatica."

Answered by AI

Have prior studies demonstrated the efficacy of ultrasound-guided adductor canal block with a local anesthetic?

"At present, 211 medical trials are taking place for Ultrasound-guided adductor canal block with local anesthetic; 53 of these studies have entered Phase 3. Most research sites can be found in Duarte, California; nonetheless, there exist 1461 other locations participating in the study worldwide."

Answered by AI

Is there eligibility criteria that I must meet in order to be part of this research endeavor?

"Eligibility for this trial mandates that individuals have already undergone total knee arthroplasty (TKA) and are aged between 18 to 80 years old. Approximately 120 people will be chosen as participants."

Answered by AI

How many individuals have the capacity to join this research initiative?

"Affirmative. The data published on clinicaltrials.gov suggests that this medical experiment, which was first listed on March 1st 2021, is still in the process of patient recruitment. Approximately 120 individuals will be required at a single research facility."

Answered by AI

Does Ultrasound-guided adductor canal block with local anesthetic pose any potential risks for individuals?

"Ultrasound-guided adductor canal block with local anesthetic has been approved, thus it was deemed a score of 3 on our scale."

Answered by AI

Is it possible to participate in this clinical inquiry at the present time?

"Data hosted on clinicaltrials.gov demonstrates that this research is actively looking for participants; the initial post was made March 1st 2021 and recently updated April 26th 2022."

Answered by AI