NCT06045936 · Mayo Clinic
A Study of Contralateral Limb Block
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Lidocaine
2 teaspoons of 2% lidocaine injection
DRUG
Placebo
Saline injection
Primary outcome measures
Change in pain
Time frame: Baseline, 60 minutes post injection
Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.
Change in Functional Improvement
Time frame: Baseline, 5 days post-injection
Measured using self-reported 20-item Orthotic and Prosthetics User's Survey (OPUS) Lower Extremity Functional Status Measurement survey. Total scores range from 0-100 scale with higher scores indicating a better outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Mankato, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 6, 2026 · Source of record for eligibility and locations