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Local Anesthetic
Sciatic Nerve Block for Amputation-Related Pain
Phase 4
Recruiting
Led By David Walega, MD,MSCI
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than 18 years of age at day of enrollment
PLP/RLP in affected amputated limb > 4 on NRS26
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 hours
Awards & highlights
Study Summary
This trial is testing whether a sciatic nerve block can provide pain relief for people with chronic, refractory phantom limb pain or residual limb pain. The hypothesis is that the block will provide immediate, clinically meaningful pain reduction for patients.
Who is the study for?
This trial is for adults over 18 with chronic phantom or residual limb pain after lower extremity amputation, experiencing pain for more than 6 months despite trying various treatments. They must be willing to undergo a nerve block and not be using high doses of opioids or have had recent other interventional pain treatments.Check my eligibility
What is being tested?
The study tests if a sciatic nerve block on the limb opposite the amputated one can significantly reduce pain. Participants will receive an injection of either lidocaine (an anesthetic) or saline (a placebo) to see if there's at least a 50% improvement in their reported pain levels.See study design
What are the potential side effects?
Possible side effects from the lidocaine may include temporary numbness, tingling sensations, weakness in the injected leg, or allergic reactions. Saline injections are generally safe but could cause minor discomfort at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Select...
I experience significant pain in my amputated limb.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of the proportions of participants reporting ≥ 50% improvement in NRS pain score from baseline at 15 minutes in treatment and sham groups
Secondary outcome measures
Demographic factors associated with large improvement in NRS pain score
Mean and SD of average daily steps recorded at 24, 48, 72, 96, 120 hours post-saline and lidocaine injections (via Modus StepWatch™ or Evolution EvoWalk™)
Mean and SD of change in Groningen Activity Restriction Scale (GARS) score immediately post-injection and conclusion of washout (5 days) in saline and lidocaine groups
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment group 2% lidocaineExperimental Treatment1 Intervention
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
Group II: Sham preservative free salinePlacebo Group1 Intervention
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,644 Total Patients Enrolled
David Walega, MD,MSCIPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pain for over 6 months and tried various treatments without success.I am over 18 years old.I haven't had any pain treatments on my amputated limb in the last 30 days.I do not have any severe uncontrolled medical conditions.I am currently taking more than 50 mg of pain medication daily.My leg pain is not caused by nerve damage.I cannot have a diagnostic nerve block due to health reasons.I haven't used experimental pain medication or joined another clinical trial in the last 30 days.I experience significant pain in my amputated limb.I am willing to have a procedure to diagnose nerve pain.I had a leg amputation over a year ago.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group 2% lidocaine
- Group 2: Sham preservative free saline
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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