Peripheral Nerve Stimulation for Postoperative Pain

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

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery. The current project is a multicenter, randomized, quadruple-masked, placebo/sham-controlled, parallel-arm pragmatic clinical trial to determine the effects of percutaneous PNS on postoperative analgesia and opioid requirements, as well as physical and emotional functioning, the development of chronic pain, and ongoing quality of life.

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 data supports the effectiveness of the treatment Percutaneous Peripheral Nerve Stimulation for postoperative pain?

Percutaneous Peripheral Nerve Stimulation (PNS) has been shown to help reduce pain and the need for opioids (strong painkillers) after surgery, based on studies that have used it for chronic pain and some early research on postoperative pain. While more research is needed, initial findings suggest it could be a promising option for managing pain after surgery. ^{1 2 3 4 5}

Is peripheral nerve stimulation safe for humans?

Peripheral nerve stimulation has been used safely for many years to treat chronic pain, and while there are some hardware-related complications, it is generally considered safe for humans. ^{1 2 6 7 8}

How is percutaneous peripheral nerve stimulation different from other treatments for postoperative pain?

Percutaneous peripheral nerve stimulation is unique because it uses a small lead to deliver electric currents to nerves, providing pain relief without the need for drugs. Unlike traditional methods, it avoids side effects like motor blockade and sensory deficits, and it can be applied using ultrasound guidance for precise placement. ^{1 2 3 7 9}

Research Team

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study. [2022]

2. England 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The Emerging Role of Peripheral Nerve Stimulation in Postoperative Analgesia. [2023]

5. New Zealand 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Acute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system. [2022]