RecruitingPhase 4NCT06045936
A Study of Contralateral Limb Block
Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
Sponsor
Mayo Clinic
Enrollment
20 participants
Start Date
Jun 18, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria7
- 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
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Interventions
DRUGLidocaine
2 teaspoons of 2% lidocaine injection
DRUGPlacebo
Saline injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06045936