Evidence map›Paper›PMID 41005804›Full record

ArticleRegional anesthesia and pain medicine2026

Percutaneous analgesic device enabling both local anesthetic delivery and electrical stimulation (neuromodulation) of peripheral nerves: a pilot feasibility study (case series).

Brian M Ilfeld, Engy T Said, Brian H Park, Sanjay K Sinha, Bryan Leek, Matthew J Meunier, Ian M Foran, Andrew Hurvitz, William T Kent, Alexandra K Schwartz and 4 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Regional anesthesia and pain medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06818708 (A Randomized, Single-Blinded, Sham-Controlled Study Evaluating the Efficacy and Safety of RELAY, a Device Enabling Both Local Anesthetic Delivery and Neuromodulation Following Shoulder or Foot Surgery), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06818708 nacompletednot on this map

A Randomized, Single-Blinded, Sham-Controlled Study Evaluating the Efficacy and Safety of RELAY, a Device Enabling Both Local Anesthetic Delivery and Neuromodulation Following Shoulder or Foot Surgery: Single Arm Training Run-In Phase

TypeinterventionalSponsorUniversity of California, San DiegoRan2025 to 2025Enrolled20ConditionsRotator Cuff Injuries, Shoulder Disease, Hallux Valgus, Ankle ArthropathyArmsExperimental Treatment
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Brian M IlfeldDepartment of Anesthesiology, University of California San Diego, La Jolla, California, USA bilfeld@health.ucsd.edu.ORCID http://orcid.org/0000-0002-6144-3273
Engy T SaidDepartment of Anesthesiology, University of California San Diego, La Jolla, California, USA.ORCID http://orcid.org/0000-0002-7897-1670
Brian H ParkDepartment of Anesthesiology, University of California San Diego, La Jolla, California, USA.
Sanjay K SinhaDepartment of Anesthesiology, St Francis Hospital, Columbus, Ohio, USA.
Bryan LeekDepartment of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA.
Matthew J MeunierDepartment of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA.
Ian M ForanDepartment of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA.
Andrew HurvitzDepartment of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA.
William T KentDepartment of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA.
Alexandra K SchwartzDepartment of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA.
Baharin AbdullahDepartment of Anesthesiology, University of California San Diego, La Jolla, California, USA.
Rafael AlkabalanSchool of Medicine, University of California San Diego, La Jolla, California, USA.
Nathan LauSchool of Medicine, University of California San Diego, La Jolla, California, USA.
John J FinneranDepartment of Anesthesiology, University of California San Diego, La Jolla, California, USA.ORCID http://orcid.org/0000-0002-0955-155X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA novel device integrating both local anesthetic delivery and peripheral nerve stimulation (PNS) to treat postoperative pain is under development. The device uses a catheter-over-needle design that permits ultrasound-guided percutaneous insertion. An integrated electrode and pulse generator enable PNS for up to 28 days. Such an approach may represent a paradigm shift in postoperative pain management by enabling the delivery of (1) a single-injection peripheral nerve block, (2) a continuous peripheral nerve block, and (3) neuromodulation-all through a single system that can be placed in a timeframe comparable with that of a traditional single-injection nerve block. The current prospective pilot study was executed under a US Food and Drug Investigational Device Exemption to develop insertion and management protocols, as well as assess the feasibility and safety of using the device to treat postoperative pain.

methodsPreoperatively, adults (n=20) undergoing moderate-to-severely painful ambulatory shoulder or foot/ankle surgery had a device (RELAY, Gate Science, Moultonborough, NH) inserted under ultrasound guidance adjacent to the brachial plexus or sciatic nerve, respectively. Accurate insertion was confirmed with a 10 mL bolus of lidocaine

resultsDuring the first seven postoperative days, the median (IQR) "average" daily

conclusionsThis novel device successfully delivered a single-injection local anesthetic bolus, a continuous perineural infusion, and concurrent/subsequent electrical current. A randomized, sham-controlled clinical trial appears warranted. CLINICALTRIALSGOV : NCT06818708.

Indexed as

Anesthetics, LocalDrug Delivery SystemsElectric Stimulation TherapyNerve BlockPeripheral NervesPostoperative PainTranscutaneous Electric Nerve StimulationAdultAgedEquipment DesignFeasibility StudiesFemaleHumansMaleMiddle AgedPain MeasurementAnesthetics, LocalAnalgesiaNeuromodulationPostoperative Pain

Identifiers

PMID41005804
PMCPMC13151445

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.