Status:

RECRUITING

A Study of Contralateral Limb Block

Lead Sponsor:

Mayo Clinic

Conditions:

Limb Pain, Phantom

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 contralatera...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 18 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06045936

Start Date

June 18 2024

End Date

December 1 2026

Last Update

January 6 2026

Active Locations (1)

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Mayo Clinic Health System - Mankato

Mankato, Minnesota, United States, 56001