Lidocaine for Phantom Limb Pain

Overseen by Cole Cheney, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Mayo Clinic

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.

Research Team

Cole Cheney, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

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

I had a leg amputation over a year ago.

I have had pain for over 6 months and tried various treatments without success.

Exclusion Criteria

My leg pain is not caused by nerve damage.

I have not had any pain treatment in my amputated limb in the last 30 days.

I take more than 50 mg of pain medication daily.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a lidocaine injection or a placebo injection in the back of their residual limb

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain, disability, and functional improvement

5 days

2 visits (in-person)

Treatment Details

Interventions

• Contralateral Limb Block (Local Anesthetic)

Trial Overview 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.

Participant Groups

Group I: Lidocaine Group Experimental Treatment 1 Intervention

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

Group II: Sham Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine