Peripheral Nerve Stimulation for Postoperative Pain

No longer recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Opioids, Antiplatelets, Anticoagulants

Disqualifiers: Chronic pain, Anxiety, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage post-surgery pain without opioids, which often cause unwanted side effects. The treatment, called Percutaneous Peripheral Nerve Stimulation, involves placing a small device near a nerve using a needle before surgery. This device sends tiny electrical pulses to block pain. Researchers aim to determine if this method can reduce opioid use and improve recovery after painful surgeries like rotator cuff repair or ankle surgery. Suitable candidates for this trial are those planning specific surgeries and will receive a nerve block for pain management. As an unphased trial, it offers patients the chance to contribute to innovative pain management research without the risks associated with opioids.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been using chronic pain medications like opioids daily in the two weeks before surgery.

What prior data suggests that this technique is safe for postoperative pain management?

Research has shown that percutaneous peripheral nerve stimulation (PNS) can reduce pain and the need for opioids after surgery without causing systemic side effects. In one study, participants experienced less pain and used fewer opioids during the first week post-surgery. Another study found that 73% of participants reported significant improvements in how pain affected their daily lives after using PNS for 60 days.

While most people benefit from PNS, about 10-20% may still experience ongoing pain after surgery. The FDA has approved the devices used in this treatment for managing post-surgical pain for up to 60 days. This approval indicates a level of safety, as the treatment has been reviewed for similar uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for postoperative pain rely on medications like opioids or NSAIDs, which can have significant side effects or dependency issues. But percutaneous peripheral nerve stimulation (PNS) works differently by using electrical currents to directly target the nerves responsible for pain. This technique involves an ultrasound-guided placement of a lead near the nerves and a wearable stimulator that generates these currents, offering a non-drug-based alternative. Researchers are excited about PNS because it has the potential to reduce pain effectively without the side effects of traditional medications. Additionally, this method could lead to faster recovery times and a reduced need for pain medication.

What evidence suggests that percutaneous peripheral nerve stimulation is effective for postoperative pain?

Studies have shown that percutaneous peripheral nerve stimulation (PNS), one of the treatments tested in this trial, can significantly reduce pain and lessen the need for opioids after surgery. Research indicates that many patients experience up to 63% less pain, with most reporting only mild or no pain following the treatment. Importantly, this drug-free method avoids common opioid side effects, such as nausea or dizziness. Additionally, PNS has proven effective in reducing long-term pain, as observed in patients with chronic pain issues. These findings suggest that PNS could safely and effectively manage post-surgical pain without relying on medications. Participants in this trial may receive either the active PNS treatment or a sham comparator to evaluate PNS's effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a one-time nerve block injection for pain relief after surgery.

I am having surgery for my shoulder, ankle, or bunion.

Exclusion Criteria

I have been diagnosed with an anxiety disorder.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead Implantation

Preoperative insertion of percutaneous lead to target nerves under ultrasound guidance

1 day

1 visit (in-person)

Treatment

Participants receive either active or sham percutaneous peripheral nerve stimulation post-surgery

14 days

Daily monitoring (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and remote)

What Are the Treatments Tested in This Trial?

Interventions

• Percutaneous Peripheral Nerve Stimulation
• Sham

Trial Overview

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.

How Is the Trial Designed?

Group I: Peripheral Nerve Stimulation Experimental Treatment 1 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: Sham Placebo Group 1 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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

Ultrasound-guided percutaneous peripheral nerve stimulation (PNS) is a promising method for managing acute postoperative pain, offering advantages over traditional local anesthetic blocks by avoiding motor and sensory deficits.

PNS may help reduce opioid use after surgery, and while initial studies show its effectiveness, more large-scale randomized controlled trials are needed to confirm its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system. Gabriel, RA., Ilfeld, BM.[2022]

Peripheral nerve stimulation is emerging as a low-risk, opioid-sparing option for managing acute postoperative pain, which is important given the ongoing opioid crisis.

Current literature suggests that peripheral nerve stimulation can effectively enhance postsurgical analgesia, but further studies are needed to fully understand its short- and long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Peripheral Nerve Stimulation in Postoperative Analgesia. Cho, AM., Xiong, JS., Burns, SL.[2023]

A multicenter trial is investigating the effectiveness of percutaneous peripheral nerve stimulation (PNS) in reducing postoperative pain and opioid use after orthopedic surgeries, with participants receiving either active stimulation or a sham treatment for 14 days.

If successful, percutaneous PNS could provide effective pain relief without the risks associated with opioids, such as addiction and overdose, potentially transforming how postoperative pain is managed in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain. Ilfeld, BM., Gelfand, H., Dhanjal, S., et al.[2021]

The distal to proximal neurostimulator lead revision technique is a safe and effective method for adjusting lead positions in patients with chronic pain, as demonstrated in a case series of 3 patients.

All patients experienced over 50% pain reduction at long-term follow-up, indicating that this technique can provide significant relief without the need for replacing the entire neurostimulator system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. Mammis, A., Mogilner, AY.[2014]

Peripheral nerve stimulation (PNS) has strong evidence supporting its effectiveness for treating various pain conditions, including chronic migraines and failed back surgery syndrome, based on a systematic review of 20 randomized controlled trials and 33 observational studies.

Newer, less invasive technologies for electrode placement make PNS a promising option for managing complex pain disorders, but it should be used carefully as an adjunct treatment after proper patient evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Clinical Guidelines from the American Society of Pain and Neuroscience for the Use of Implantable Peripheral Nerve Stimulation in the Treatment of Chronic Pain. Strand, N., D'Souza, RS., Hagedorn, JM., et al.[2022]

In a multicenter study involving 66 participants undergoing various orthopedic surgeries, percutaneous peripheral nerve stimulation significantly reduced postoperative pain and opioid consumption compared to sham stimulation, with active stimulation resulting in a median opioid use of only 5 mg versus 48 mg in the sham group.

Patients receiving active stimulation reported lower average pain scores (1.1) compared to those receiving sham treatment (3.1), indicating that this technique effectively alleviates pain without systemic side effects during the first week after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study. Ilfeld, BM., Plunkett, A., Vijjeswarapu, AM., et al.[2022]

In a retrospective study of 46 patients with painful nerve injuries, peripheral nerve stimulation (PNS) provided good pain relief (50% or more reduction) in 78% of cases over a follow-up period of 3 to 16 years.

The average pain intensity significantly decreased from a visual analog scale (VAS) score of 69 before surgery to 24 after PNS, indicating that PNS is an effective long-term treatment option for selected patients with isolated painful neuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. Eisenberg, E., Waisbrod, H., Gerbershagen, HU.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8249357/

Percutaneous Peripheral Nerve Stimulation ...

Estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption.

2.

asra.com

asra.com/docs/default-source/events-education-documents/pm23/abstract-4607.pdf?sfvrsn=6e98e7e7_1

percutaneous pns relieves persistent postoperative ...

Despite positive results for many patients, approximately 10-20% of patients continue to experience persistent postoperative pain following TKA (i.e., pain >3 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12085521/

Four-Year Follow-Up from a Prospective, Multicenter Study of ...

The present work explores the long-term clinical outcomes of Percutaneous 60-day PNS for chronic LBP approximately 4 years after initial treatment.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772594423000699

Durable patient-reported outcomes following 60-day ...

Treatment of CLBP with 60-day percutaneous PNS treatment produced clinically meaningful improvements in average pain intensity, disability, and/or pain ...

5.

sprpainrelief.com

sprpainrelief.com/press-releases/real-world-data-over-6100-patients-corroborates-significant-pain-reduction-prior

Real-world data from over 6,100 patients corroborates ... - SPR

Among these responders, mean percent pain relief was 63 percent, with the majority reporting mild or no pain at the end of treatment. Previously ...

6.

link.springer.com

link.springer.com/article/10.1007/s40122-025-00737-3

Four-Year Follow-Up from a Prospective, Multicenter Study ...

The present work explores the long-term clinical outcomes of Percutaneous 60-day PNS for chronic LBP approximately 4 years after initial treatment.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02898103

Study Details | NCT02898103 | Percutaneous Peripheral ...

Of note, the data derived from the chronic pain literature suggests that there is a "carry over" effect following stimulation: analgesia is provided even after ...