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Device
Peripheral Nerve Stimulation for Postoperative Pain
N/A
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
Undergoing one of the following surgical procedures: rotator cuff repair, ankle arthrodesis or arthroplasty, hallux valgus correction.
18 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as months 1,4 and 12.
Awards & highlights
Study Summary
This trial is studying a non-opioid pain reliever for people who have undergone surgery. The goal is to see if it can reduce or obviate the need for opioids, which have undesirable and sometimes dangerous side effects.
Who is the study for?
This trial is for adults over 18 who are having surgery for bunions, rotator cuff repair, or ankle fusion and will receive a nerve block for pain. It's not open to those using daily painkillers recently, with bleeding disorders, pregnant women, substance abuse history, weakened immune systems, on certain blood thinners (except aspirin), prisoners, without phone access, allergic to skin-contact materials or with chronic pain elsewhere.Check my eligibility
What is being tested?
The study tests percutaneous peripheral nerve stimulation (PNS) against a sham procedure to manage post-surgery pain and reduce opioid use. PNS involves placing an electric lead near a nerve before surgery; after the operation it delivers small currents for potent pain control. The trial is multicenter and placebo-controlled.See study design
What are the potential side effects?
Percutaneous PNS aims to provide strong pain relief without systemic side effects like those from opioids. However, potential risks may include local irritation at the site of electrode placement or discomfort during insertion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery for my shoulder, ankle, or bunion.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as months 1,4 and 12.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as months 1,4 and 12.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average pain during first postoperative week
Opioid consumption during first postoperative week
Secondary outcome measures
Average pain
Brief pain Inventory, short form (interference subscale)
Defense and Veterans Pain Rating Scale
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Peripheral Nerve StimulationExperimental Treatment1 Intervention
ACTIVE percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electrical current
Group II: ShamPlacebo Group1 Intervention
SHAM percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does NOT generate electrical current
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral Nerve Stimulation
2016
Completed Phase 1
~1380
Find a Location
Who is running the clinical trial?
Congressionally Directed Medical Research ProgramsFED
47 Previous Clinical Trials
6,328 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,157 Total Patients Enrolled
Brian M Ilfeld, MD, MSPrincipal InvestigatorUniversity of California, San Diego
19 Previous Clinical Trials
1,291 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an anxiety disorder.I am scheduled for a one-time nerve block injection for pain relief after surgery.You are allergic to materials that come in contact with your skin, such as dressings, bandages, or tape.I have weakness or problems with certain nerves.I have had chronic pain for more than 3 months in a part of my body other than the limb where I had surgery.You have an implanted device in your body that uses electrical stimulation, such as a spinal cord stimulator or pacemaker, which may interfere with the study.My immune system is weak due to treatments or conditions I have.I am not on blood thinners other than aspirin.I am having surgery for my shoulder, ankle, or bunion.I have been using painkillers daily for more than 4 weeks.I have a history of bleeding disorders.You have a history of drug or alcohol abuse.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Sham
- Group 2: Peripheral Nerve Stimulation
Awards:
This trial has 0 awards, including: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.
How widely is this research being conducted?
"Six trial sites are available for this investigation. These include University of California, San Diego in San Diego, Walter Reed National Military Medical Center in Bethesda and Naval Medical Center San Diego in Cleveland; three additional locations exist across the country."
Answered by AI
Is there still an opportunity to partake in this experiment?
"Clinicaltrials.gov confirms that this research program is currently not enrolling patients, despite originating on January 26th 2021 and being updated as recently as November 6th 2022. However, there are 21 other trials actively taking partisipants at the present moment."
Answered by AI
What aims is this trial seeking to accomplish?
"The primary assessment of this trial, which will occur from Postoperative days 0-7 and be collected on days 1, 2, 3, 4 and 7 for the last 24 hours at each marker point is Average pain during first postoperative week. Secondary measurements are Opioid consumption (Cumulative opioid dose of preceding 24hrs), Post-traumatic Stress Disorder checklist (A 20-question self-report gauge that reflects signs of PTSD validated in military/veteran/civilian populations), Worst/maximum Pain level as measured by a numerical rating scale with range 0=no distress to 10=most severe imaginable anguish)."
Answered by AI
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