A Study of Contralateral Limb Block

NCT06045936 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 22-010792
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in pain

  Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.

  Baseline, 60 minutes post injection

• Change in Functional Improvement

  Measured using self-reported 20-item Orthotic and Prosthetics User's Survey (OPUS) Lower Extremity Functional Status Measurement survey. Total scores range from 0-100 scale with higher scores indicating a better outcome.

  Baseline, 5 days post-injection

Secondary Outcomes (3)

• Change in disability

  Baseline, 5 days post-injection

• Change in Pressure-Pain Algometry

  Baseline, 5 days post-injection

• Step Count

  5 days post-injection

Study Arms (2)

Lidocaine Group

EXPERIMENTAL

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

Drug: Lidocaine

Sham Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lidocaine DRUG

2 teaspoons of 2% lidocaine injection

Lidocaine Group

Placebo DRUG

Saline injection

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Health System - Mankato

Mankato, Minnesota, 56001, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Phantom Limb

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Cole Cheney, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: June 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)