Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

  • STATUS
    Recruiting
  • End date
    Mar 11, 2024
  • participants needed
    20
  • sponsor
    Northwestern University
Updated on 11 December 2021
heat
nerve block
lidocaine
amputation of the lower limb
limb pain
nerve blocks
transcutaneous electrical nerve stimulation

Summary

Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Also, contribute to the basic science understanding of the crossed-withdraw reflex by demonstrating a known animal model phenomenon in human participants. Hypothesis: Contralateral limb sciatic nerve anesthetic block with 2% lidocaine provides immediate clinically meaningful pain reduction, defined as the proportion of patients with at least 50% improvement in NRS pain score in PLP/RLP when compared to sham.

Details
Condition Pain, Pain (Pediatric), ache, Amputation, Limb Preservation and Amputation, Acute Pain Service, Post-Surgical Pain
Treatment 10 mL 2% lidocaine, 10 mL preservative free saline
Clinical Study IdentifierNCT05046639
SponsorNorthwestern University
Last Modified on11 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Age greater than 18 years of age at day of enrollment
\. 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
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