What is Lidocaine studying for limb pain after amputation?

Lidocaine is being studied to see if injecting it near the sciatic nerve of the intact limb can reduce pain in the opposite limb after amputation. This trial, sponsored by Mayo Clinic, aims to understand if this pain treatment could help people with phantom and residual limb pain. Participants will receive either Lidocaine or a placebo injection to compare effects.

Who may be eligible for this limb pain clinical trial?

Adults 18 years or older with a lower leg amputation performed over 12 months ago may be eligible. Participants must have phantom or residual limb pain rated above 4 and have tried other treatments for at least 2 months without success. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this limb pain clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel-related costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID06045936

Testing Lidocaine Injection for Pain Relief in Patients with Lower Limb Amputation Double-Blind Study Comparing Lidocaine and Placebo for Phantom and Residual Limb Pain

Led by Mayo Clinic · Updated on 2026-01-06

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether an anesthetic called Lidocaine may be effective when injected around the sciatic nerve of the intact limb in patients experiencing pain in the opposite limb after limb loss. This study focuses on people with phantom limb pain or residual limb pain who have undergone lower extremity amputation more than a year ago. The trial is a double-blind, randomized controlled study to assess pain relief and functional improvement. Participants will be randomly assigned to receive either a 2% lidocaine injection or a saline placebo injection in the back of their residual limb. The study compares these two treatments to understand their effects on pain and function. The trial is scheduled to start in June 2024 and will monitor participants shortly after injection and for several days following treatment. During the study, participants will be assessed for changes in pain levels at baseline and 60 minutes after injection, as well as changes in functional ability and disability five days post-injection. Additional measurements include pressure-pain sensitivity and step counts five days after treatment. Researchers will closely monitor participants and collect data related to these outcomes to evaluate the impact of the injections over time.

CONDITIONS

Brief Title

A Study of Contralateral Limb Block

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Lower extremity amputation performed more than 12 months before study enrollment
Phantom limb pain or residual limb pain in affected amputated limb greater than 4 on a pain rating scale
Pain lasting more than 6 months despite at least 2 months of conservative therapies including medications and physical treatments
Willingness to undergo image guided diagnostic nerve block

You will not qualify if you...

Refusal or inability to participate or provide consent
Contraindications to diagnostic nerve block
Non-neurogenic source of phantom or residual limb pain
Current opioid use exceeding 50 morphine milligram equivalents per day
Interventional pain treatment in the residual limb within the last 30 days
Severe uncontrolled medical conditions such as hypertensive crisis or decompensated hypothyroidism
Use of investigational pain drug within past 30 days or enrollment in another clinical trial

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