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Local Anesthetic
Continuous Peripheral Nerve Blocks for Phantom Limb Pain
Phase 4
Waitlist Available
Led By Brian M Ilfeld, MD, MS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months 1, 3, 6, 9, and 12
Awards & highlights
Study Summary
This trial will test whether a continuous peripheral nerve block, which numbs the nerves around an amputation site, can prevent phantom limb pain.
Who is the study for?
This trial is for individuals scheduled for unilateral lower limb amputation who are willing to have a nerve block infusion for 7 days, including after hospital discharge. They must not have liver or kidney issues, allergies to study meds, be pregnant or incarcerated, and must be able to communicate with researchers.Check my eligibility
What is being tested?
The study tests if using a high-concentration continuous peripheral nerve block (CPNB) around the time of leg amputation can improve recovery by reducing phantom limb pain and opioid use. Participants will either receive the experimental CPNB or a control version in this randomized, triple-masked trial.See study design
What are the potential side effects?
While CPNB generally avoids systemic side effects by targeting specific nerves with local anesthetic, potential risks may include infection at the catheter site or discomfort where the tiny tube enters the skin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a leg amputation below the hip that includes part of my foot.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, months 1, 3, 6, 9, and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months 1, 3, 6, 9, and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Beck Depression Inventory
Locomotor Capabilities Index-5
Masking assessment
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Bupivacaine 0.3% [or ropivacaine 0.5%] infusion for 7 days via femoral and sciatic perineural catheters
Group II: ControlExperimental Treatment1 Intervention
Bupivacaine 0.1% [or ropivacaine 0.2%] infusion for 1 day followed by normal saline for a total of 7 days via femoral and sciatic perineural catheters
Find a Location
Who is running the clinical trial?
The Cleveland ClinicOTHER
1,026 Previous Clinical Trials
1,365,873 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,259 Previous Clinical Trials
14,820,450 Total Patients Enrolled
Boston VAUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver or kidney problems.You cannot talk to the researchers.I am scheduled for a leg amputation below the hip that includes part of my foot.I weigh less than 45 kg.I am willing to undergo a 7-day perineural infusion treatment.I am scheduled for pain relief via nerve blocks around surgery time.You are in prison.I don't have conditions that prevent safe catheter use for pain management.I am willing to have a nerve block infusion at home after leaving the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Treatment
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this therapeutic process acquired the necessary governmental approvals?
"As this is a Phase 4 trial, which indicates approval by the FDA and other regulatory bodies, our team assesses its safety to be 3 on a scale of 1-3."
Answered by AI
Are there vacancies available for individuals to partake in this trial?
"According to clinicaltrials.gov, this study is not currently seeking applicants; it was originally published on March 23rd 2018 and last updated October 29th 2022. Nevertheless, 27 other trials are actively admitting participants as of now."
Answered by AI
How many administrative sites oversee this research?
"This trial is available at 8 medical institutions, including the Massachusetts General Hospital in Houston and University of Texas MD Anderson Cancer Center in Cleveland. Additionally, patients can enroll at the Cleveland Clinic in San Diego or any of 5 other locations."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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