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Carbamazepine is the first-line medical management of TN. However, side effects are common. Currently, there is no ideal treatment for TN. Since there is a known abnormality of Na<jats:sup>+<\/jats:sup>channels in the trigger zone, 5% lidocaine-medicated plaster (LMP), which can block the Na<jats:sup>+<\/jats:sup>channels on A\u03b4 and C fibres, is an effective treatment method in many chronic pain conditions. A case report has found the benefit of LMP for the treatment of TN without any side effects. Whether LMP is an option for the treatment of TN is worth exploring.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>The PATCH trial is a double-blind, enriched enrolment with randomised withdrawal, vehicle-controlled trial, aiming to explore the effects and safety of LMP in patients with TN. There is a 3-week initial open-label phase, followed by a 4-week double-blind treatment phase for responders. In the double-blind phase, patients will have to withdraw from this PATCH study if they meet one of the following criteria for treatment failure such as: &gt;50% increase in pain intensity or paroxysms, lack of efficacy or side effects. The primary outcome will be the number of treatment failures. Adverse events will also be monitored throughout the study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>This study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital (approval number: KY 2020-102-02). The results will be disseminated in international academic meetings and published in peer-reviewed journals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04570293\">NCT04570293<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045493","type":"journal-article","created":{"date-parts":[[2021,8,2]],"date-time":"2021-08-02T16:22:06Z","timestamp":1627921326000},"page":"e045493","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["The PATCH trial: efficacy and safety of 5% lidocaine-medicated plaster for the treatment of patients with trigeminal neuralgia: a study protocol for a multicentric, double-blind, enriched enrolment randomised withdrawal, vehicle-controlled study"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04570293","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7734-4192","authenticated-orcid":false,"given":"Chunmei","family":"Zhao","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7360-9747","authenticated-orcid":false,"given":"Niti","family":"Shrestha","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongbing","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Shen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lan","family":"Meng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bifa","family":"Fan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3584-0355","authenticated-orcid":false,"given":"Fang","family":"Luo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,8,2]]},"reference":[{"key":"2024112509051397000_11.8.e045493.1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"2024112509051397000_11.8.e045493.2","doi-asserted-by":"publisher","DOI":"10.1136\/practneurol-2013-000536"},{"key":"2024112509051397000_11.8.e045493.3","doi-asserted-by":"publisher","DOI":"10.1016\/0304-3959(94)90086-8"},{"key":"2024112509051397000_11.8.e045493.4","doi-asserted-by":"publisher","DOI":"10.3171\/jns.2002.96.3.0532"},{"key":"2024112509051397000_11.8.e045493.5","doi-asserted-by":"publisher","DOI":"10.1097\/00002508-200201000-00002"},{"key":"2024112509051397000_11.8.e045493.6","doi-asserted-by":"crossref","DOI":"10.1016\/j.mehy.2020.109801","article-title":"Mechanism underlying cranial nerve rhizopathy","volume":"142","author":"Liu","year":"2020","journal-title":"Med Hypotheses"},{"key":"2024112509051397000_11.8.e045493.7","doi-asserted-by":"crossref","first-page":"818","DOI":"10.1016\/j.mehy.2009.12.007","article-title":"Trigeminal neuralgia may be caused by abnormality of the trigger zone","volume":"74","author":"Liu","year":"2010","journal-title":"Med Hypotheses"},{"key":"2024112509051397000_11.8.e045493.8","doi-asserted-by":"crossref","first-page":"784","DOI":"10.1016\/S1474-4422(20)30233-7","article-title":"Advances in diagnosis, classification, pathophysiology, and management of trigeminal neuralgia","volume":"19","author":"Bendtsen","year":"2020","journal-title":"Lancet Neurol"},{"key":"2024112509051397000_11.8.e045493.9","article-title":"Carbamazepine for chronic neuropathic pain and fibromyalgia in adults","volume":"4","author":"Wiffen","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"2024112509051397000_11.8.e045493.10","doi-asserted-by":"publisher","DOI":"10.1111\/ane.12901"},{"key":"2024112509051397000_11.8.e045493.11","doi-asserted-by":"publisher","DOI":"10.1002\/ana.410150306"},{"key":"2024112509051397000_11.8.e045493.12","first-page":"243","article-title":"Definite and sustained improvement with pimozide of two patients with severe trigeminal neuralgia. 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