Recruiting NCT06045936
A Study of Contralateral Limb Block
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine, Placebo.
- Who it may be relevant to
- Registry conditions: Limb Pain, Phantom. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
Overview
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.
Interventions
- Drug Lidocaine
2 teaspoons of 2% lidocaine injection - Drug Placebo
Saline injection
Primary outcome measures
- Change in pain [Time frame: Baseline, 60 minutes post injection]
- Change in Functional Improvement [Time frame: Baseline, 5 days post-injection]
Secondary outcome measures (3)
- Change in disability [Time frame: Baseline, 5 days post-injection]
- Change in Pressure-Pain Algometry [Time frame: Baseline, 5 days post-injection]
- Step Count [Time frame: 5 days post-injection]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic Health System - Mankato — Mankato
Identifiers
NCT: NCT06045936 · 22-010792