Actively Recruiting
Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain A Double-Blind Randomized Controlled Trial
Led by Mayo Clinic · Updated on 2026-01-06
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration with follow-up over 5 days
Participants receive an injection of either lidocaine or placebo in the back of their residual limb to treat phantom or residual limb pain.
1 injection visit and 1 follow-up visit 5 days later
Trial Site Locations
Total: 1 location
1
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States, 56001
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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