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Lidocaine for Phantom Limb Pain

Phase 4

Waitlist Available

Led By Cole Cheney, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

PLP/RLP in affected amputated limb > 4 on NRS26

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 60 minutes post injection

Awards & highlights

Study Summary

This trial is looking at if anesthetic injections reduce pain in amputees who feel pain in the limb they no longer have.

Who is the study for?

This trial is for adults with phantom limb pain who've had a lower extremity amputation over a year ago and have been in pain for more than 6 months despite trying various treatments. They must be willing to undergo a nerve block and not be on high doses of opioids or other experimental pain drugs.Check my eligibility

What is being tested?

The study tests if Lidocaine, an anesthetic injected around the sciatic nerve of the non-amputated limb, can relieve pain in the amputated limb. Participants will either receive Lidocaine or a placebo to compare effectiveness.See study design

What are the potential side effects?

Lidocaine may cause side effects such as numbness around the injection site, dizziness, changes in blood pressure, nausea, and rarely allergic reactions. The placebo should have no active side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I experience pain in my amputated limb rated over 4 on a pain scale.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 60 minutes post injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 60 minutes post injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 60 minutes post injection for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Functional Improvement

Change in pain

Secondary outcome measures

Change in Pressure-Pain Algometry

Change in disability

Step Count

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lidocaine GroupExperimental Treatment1 Intervention

Subjects will receive a lidocaine injection in the back of their residual limb.

Group II: Sham GroupPlacebo Group1 Intervention

Subjects will receive a placebo injection in the back of their residual limb.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine

2011

Completed Phase 4

~1360

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,764 Total Patients Enrolled

Cole Cheney, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

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

Has the Lidocaine Group been accepted by the Food and Drug Administration?

"There is ample evidence of Lidocaine Group's safety, so it earned a score of 3."

Answered by AI

Is there still availability for participants in this experiment?

"From what we can glean on clinicaltrials.gov, this study is no longer recruiting participants; it first posted in December 1st 2023 and was last modified on September 13th of the same year. Nevertheless, there are still 25 other trials searching for candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Contralateral Limb Block

Cole W. Cheney 2024. "A Study of Contralateral Limb Block". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045936.