{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T02:00:20Z","timestamp":1788487220502,"version":"build-2803163510"},"reference-count":11,"publisher":"BMJ","license":[{"start":{"date-parts":[[2025,9,25]],"date-time":"2025-09-25T00:00:00Z","timestamp":1758758400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Gate Science"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Reg Anesth Pain Med"],"accepted":{"date-parts":[[2025,9,3]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>A 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\u2014all 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Preoperatively, 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\u2009mL bolus of lidocaine <jats:italic>via<\/jats:italic> the catheter followed by bupivacaine (10\u2009mL). If a continuous infusion was indicated, a portable pump was used to infuse ropivacaine (6\u20138\u2009mL\/h, 500\u2009mL reservoir). Electric current was delivered using the integrated pulse generator for 7\u2009days, followed by removal at home. Participants were contacted for data collection on postoperative days 1\u20135, 7, 8, and 14.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>During the first seven postoperative days, the median (IQR) \u201caverage\u201d daily <jats:italic>pain intensity<\/jats:italic> as measured with the numeric rating scale (NRS) was 2 [0, 3]. Following postoperative day 1, daily average and maximum\/worst NRS was less than 2 and 5, respectively. Regarding the \u201cworst\u201d (maximum) pain level over the entire study period of Days 0\u201314, 7 (35%) experienced mild pain (NRS&lt;4), 10 (50%) moderate pain (NRS 4\u20137), and 3 (15%) severe pain (NRS&gt;7). Cumulative oxycodone consumption the first week was a median of 43 (18, 73) mg.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinicaltrials.gov\u2003<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06818708\">NCT06818708<\/jats:ext-link>\n                  <\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rapm-2025-107029","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T13:44:16Z","timestamp":1759931056000},"page":"rapm-2025-107029","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Percutaneous analgesic device enabling both local anesthetic delivery and electrical stimulation (neuromodulation) of peripheral nerves: a pilot feasibility study (case series)"],"prefix":"10.1136","clinical-trial-number":[{"clinical-trial-number":"nct06818708","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06818708","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6144-3273","authenticated-orcid":false,"given":"Brian M","family":"Ilfeld","sequence":"first","affiliation":[{"name":"Department of Anesthesiology, University of California San Diego, La Jolla, California, USA"},{"name":"Outcomes Research Consortium, The University of Texas Health Science Center at Houston, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7897-1670","authenticated-orcid":false,"given":"Engy T","family":"Said","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian H","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjay K","family":"Sinha","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, St Francis Hospital, Columbus, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryan","family":"Leek","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J","family":"Meunier","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian M","family":"Foran","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Hurvitz","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William T","family":"Kent","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra K","family":"Schwartz","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baharin","family":"Abdullah","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"Alkabalan","sequence":"additional","affiliation":[{"name":"School of Medicine, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Lau","sequence":"additional","affiliation":[{"name":"School of Medicine, University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0955-155X","authenticated-orcid":false,"given":"John J","family":"Finneran","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, University of California San Diego, La Jolla, California, USA"},{"name":"Outcomes Research Consortium, The University of Texas Health Science Center at Houston, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,9,25]]},"reference":[{"key":"2025092600551203000_rapm-2025-107029v1.1","doi-asserted-by":"crossref","first-page":"308","DOI":"10.1213\/ANE.0000000000001581","article-title":"Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities","volume":"124","author":"Ilfeld","year":"2017","journal-title":"Anesth Analg"},{"key":"2025092600551203000_rapm-2025-107029v1.2","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1097\/ALN.0000000000003776","article-title":"Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot 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Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rapm-2025-107029","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T13:44:18Z","timestamp":1759931058000},"score":1,"resource":{"primary":{"URL":"https:\/\/rapm.bmj.com\/lookup\/doi\/10.1136\/rapm-2025-107029"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,25]]},"references-count":11,"alternative-id":["10.1136\/rapm-2025-107029"],"URL":"https:\/\/doi.org\/10.1136\/rapm-2025-107029","relation":{},"ISSN":["1098-7339","1532-8651"],"issn-type":[{"value":"1098-7339","type":"print"},{"value":"1532-8651","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,25]]}}}