Using Lidocaine to Treat Phantom Limb Pain
Official title: Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
Run by Mayo Clinic · NCT06045936 · Data updated 2026-11-12
This study tests whether Lidocaine injections can help people who have phantom limb pain after losing a leg feel better when other treatments haven't worked.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Mankato, Minnesota) |
| Status | Recruiting |
| Started | June 18, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT06045936 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have undergone lower extremity amputation more than 12 months prior and experience significant phantom limb pain.
✕Probably not a fit
Patients with non-neurogenic sources of pain or those currently using high doses of opioids may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of Lidocaine injections around the sciatic nerve of the intact limb in patients experiencing phantom limb pain on the opposite side after lower extremity amputation. Participants must have had their amputation more than a year ago and have been suffering from pain for over six months despite other treatments. The study aims to determine if this anesthetic approach can provide relief for those with persistent pain. A placebo group will also be included for comparison.
Why it matters
Potential benefit: If successful, this approach could significantly reduce phantom limb pain for patients who have not found relief through conventional therapies.
How similar studies have gone: While similar approaches have been explored, this specific method of using contralateral limb blocks with Lidocaine is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lower extremity amputation performed more than 12 months before study enrollment * PLP/RLP in affected amputated limb \> 4 on NRS26 * Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis) * Willingness to undergo image guided diagnostic nerve block Exclusion Criteria: * Refusal / inability to participate or provide consent * Contraindications to diagnostic nerve block * Non-neurogenic source of PLP/RLP * Current opioid use \> 50 morphine milligram equivalents per day * Any interventional pain treatment in the residual limb within the last 30 days * Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism) * Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
Where it's running
-
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Cole Cheney, MD — Mayo Clinic
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.