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A Study of Contralateral Limb Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045936
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : April 2, 2024
Sponsor:
Information provided by (Responsible Party):
Cole W. Cheney, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Limb Pain, Phantom Drug: Lidocaine Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lidocaine Group
Subjects will receive a lidocaine injection in the back of their residual limb.
 Drug: Lidocaine
2 teaspoons of 2% lidocaine injection
Placebo Comparator: Sham Group
Subjects will receive a placebo injection in the back of their residual limb.
 Drug: Placebo
Saline injection


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045936


Locations
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United States, Minnesota
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States, 56001
Contact: Cole Cheney, MD    515-681-6338    cheney.cole@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Cole Cheney, MD Mayo Clinic
More Information
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Responsible Party: Cole W. Cheney, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT06045936    
Other Study ID Numbers: 22-010792
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Lidocaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action