NCT06045936PHASE4Recruiting
A Study of Contralateral Limb Block
Mayo Clinic
Start Date
6/18/2024
Completion Date
12/1/2026
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
Lidocaine
DRUG
Placebo
Conditions
Limb Pain, Phantom
Locations
Mayo Clinic Health System - Mankato
Mankato, Minnesota 56001
United States