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NCT04713098 · ClinicalTrials.gov registry record · NA

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical Trial

A NA study, sponsored by University of California, San Diego.

Completed
Registry status
NA
Development phase
250
Enrollment target

NCT04713098: Completed NA study, sponsored by University of California, San Diego.

NCT04713098 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04713098, a NA study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
NA
Development phase
250 participants
Enrollment target

Study Summary

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.

Primary Outcome

Cumulative opioid dose following recovery room discharge for days 0-7

Interventions

  • DEVICE Sham
  • DEVICE Peripheral Nerve Stimulation

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2021-01-26
Est. Completion 2025-09-22
Phase NA
University of California, San Diego

775 total trials

What the finished NCT04713098 record still lists

NCT04713098 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.

NCT04713098 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04713098 about?

NCT04713098 is a clinical study titled "Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical 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...

What is the current status of trial NCT04713098?

This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2021-01-26. Estimated completion is 2025-09-22.

What interventions are being tested in trial NCT04713098?

The interventions under investigation include: Sham (DEVICE), Peripheral Nerve Stimulation (DEVICE).

Who is sponsoring clinical trial NCT04713098?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04713098's enrollment target sits among peer trials

250 410th of 2000 higher than 1,567 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04713098, the US trial registry maintained by the National Library of Medicine. NCT04713098 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.