250 Participants Needed

Peripheral Nerve Stimulation for Postoperative Pain

Recruiting at 5 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12678

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.12379

Research Team

Brian M. Ilfeld, MD - Anesthesiology ...

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.
See 10 more

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
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

Find a Clinic Near You

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

References

Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study. [2022]
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain. [2021]
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study. [2019]
The Emerging Role of Peripheral Nerve Stimulation in Postoperative Analgesia. [2023]
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]
A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. [2014]
Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. [2018]
Long-term peripheral nerve stimulation for painful nerve injuries. [2019]
Acute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system. [2022]
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