Using Lidocaine to Treat Phantom Limb Pain
Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
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 |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Mankato, Minnesota) |
| Trial ID | NCT06045936 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who have undergone lower extremity amputation more than 12 months prior and experience significant phantom limb pain.
Not a fit: Patients with non-neurogenic sources of pain or those currently using high doses of opioids may not benefit from this study.
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 performed: While similar approaches have been explored, this specific method of using contralateral limb blocks with Lidocaine is relatively novel.
Eligibility criteria
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 this trial is running
Mankato, Minnesota
- Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Cole Cheney, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.