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NCT Number: NCT06045936

A Study of Contralateral Limb Block

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic Health System - Mankato

Mankato, Minnesota, 56001, United States

Location status: Recruiting

Location contact

Cole Cheney, MD

CONTACT

[email protected]

5156816338

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

2 teaspoons of 2% lidocaine injection

Placebo

Drug

Saline injection

Primary outcomes

  1. Change in pain

    Time frame: Baseline, 60 minutes post injection

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

  2. Change in Functional Improvement

    Time frame: Baseline, 5 days post-injection

    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.

Secondary outcomes

  1. Change in disability

    Time frame: Baseline, 5 days post-injection

    Measured using self-reported 18-item The Groningen Activity Restriction Scale (GARS) that is a general disease independent instrument for measuring disability. Total scores range from 18-72. The higher the score the greater the disability.

  2. Change in Pressure-Pain Algometry

    Time frame: Baseline, 5 days post-injection

    Qualified study personnel will measure pain pressure threshold three times at each visit with an algometer on the participant's residual limb at the point of a maximal pain as indicated by the participant during pre-block physical examination, reported in kilopascal (kPa).

  3. Step Count

    Time frame: 5 days post-injection

    Number of daily steps recorded by Modus StepWatch™ or Evolution EvoWalk™ fitted to the participant's prostheses

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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