Lidocaine for Phantom Limb Pain

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Opioids, Investigational drugs

Disqualifiers: Non-neurogenic pain, Severe conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

20 Participants Needed

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.

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

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+