Recruiting

Contralateral Limb Block

Sponsor:

Mayo Clinic

Code:

NCT06045936

Conditions

Limb Pain, Phantom

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine

Placebo

Study Details

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 contralateral side.

Conditions

Limb Pain, Phantom

Study ID

NCT06045936

Start date

Jun 18, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lidocaine Group

Subjects will receive a lidocaine injection in the back of their residual limb.

placebo comparator: Sham Group

Subjects will receive a placebo injection in the back of their residual limb.

Interventions

Lidocaine

2 teaspoons of 2% lidocaine injection

Placebo

Saline injection

Primary outcome measure

  • Change in pain [ Time Frame: Baseline, 60 minutes post injection ]
  • Change in Functional Improvement [ Time Frame: Baseline, 5 days post-injection ]

Central Contacts and Locations

Locations

Mayo Clinic Health System - Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Cole Cheney, MD

5156816338cheney.cole@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-06.