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A Study of Contralateral Limb Block

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Mayo Clinic

Status and phase

Enrolling
Phase 4

Conditions

Limb Pain, Phantom

Treatments

Drug: Placebo
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06045936
22-010792

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Lidocaine Group
Experimental group
Description:
Subjects will receive a lidocaine injection in the back of their residual limb.
Treatment:
Drug: Lidocaine
Sham Group
Placebo Comparator group
Description:
Subjects will receive a placebo injection in the back of their residual limb.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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