RECRUITING

A Study of Contralateral Limb Block

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-18

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06045936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Principal Investigator

Cole Cheney, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Health System - Mankato

Mankato, Minnesota, 56001

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Cole Cheney, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-18

Study Completion Date2024-12

Study Record Updates

Study Start Date2024-06-18

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Limb Pain, Phantom