A Phase 4 interventional study of Lidocaine and Placebo in Limb Pain, Phantom, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive a lidocaine injection in the back of their residual limb.
Drug: Lidocaine
Subjects will receive a placebo injection in the back of their residual limb.
Drug: Placebo
2 teaspoons of 2% lidocaine injection
Saline injection
Change in pain
Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.
Time frame: Baseline, 60 minutes post injection
Change in Functional Improvement
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.
Time frame: Baseline, 5 days post-injection
Change in disability
Measured using self-reported 18-item The Groningen Activity Restriction Scale (GARS) that is a general disease independent instrument for measuring disability. Total scores range from 18-72. The higher the score the greater the disability.
Time frame: Baseline, 5 days post-injection
Change in Pressure-Pain Algometry
Qualified study personnel will measure pain pressure threshold three times at each visit with an algometer on the participant's residual limb at the point of a maximal pain as indicated by the participant during pre-block physical examination, reported in kilopascal (kPa).
Time frame: Baseline, 5 days post-injection
Step Count
Number of daily steps recorded by Modus StepWatch™ or Evolution EvoWalk™ fitted to the participant's prostheses
Time frame: 5 days post-injection
Plan to share: No
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Studies of the drug tested here: Lidocaine