{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:50Z","timestamp":1790726450675,"version":"4.1.0"},"reference-count":42,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2025,6,20]],"date-time":"2025-06-20T00:00:00Z","timestamp":1750377600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Department of Surgery at Houston Methodist Hospital"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Objectives: Currently, there are a lack of data on the use of systemic lidocaine infusion in critically ill surgical patients, particularly regarding optimal dosing and monitoring. This study aimed to assess the feasibility of conducting a subsequent full-scale, randomized controlled trial (RCT) on the use of systemic lidocaine infusion in surgical intensive care units (ICUs). Methods: A single-center, prospective, single-arm pilot trial was conducted at the surgical intensive care unit (ICU) at Houston Methodist Hospital. The study population included 12 subjects over 18 years old who were admitted to the surgical ICU after open abdominal surgery. A low-dose lidocaine infusion of 10\u201330 mcg\/kg\/min within 1 h of ICU admission. Results: The feasibility outcomes encompassed recruitment, retention, and withdrawal rates. The study initially screened 18 participants, all of whom were successfully enrolled, resulting in a recruitment rate of 100%. However, 6 participants (33.3%) from the enrolled group were subsequently withdrawn for various reasons, resulting in a retention rate of 12 participants (66.7%). All 12 remaining participants were included in the analysis at the baseline stage. The safety outcomes included adverse events and serum lidocaine levels, with no serious adverse events reported. Dizziness and hypertension were the most frequently reported adverse events in their respective categories, affecting 16.7% of patients each. Four patients (33%) exhibited elevated lidocaine levels exceeding 5 mcg\/mL; however, no clinical features of lidocaine toxicity were observed. This study adhered to the CONSORT 2010 extension for pilot and feasibility trials. In accordance with these guidelines, no formal hypothesis testing for efficacy was performed. The exploratory outcomes included a reduction in opioid requirements, as measured by morphine milligram equivalents (MMEs), and pain scores. The median MMEs decreased from 22.6 on postoperative day 0 to 2.5 on day 3. The pain scores decreased by 1.09 units per day (\u03b2 = \u22121.09; 95% CI: \u22121.82 to \u22120.36; p = 0.003); however, the absence of a control group limits the robustness of this observation. Conclusions: A large-scale, randomized controlled trial to evaluate the safety and efficacy of systemic lidocaine infusion in the surgical intensive care unit (ICU) seems feasible, with minor adjustments to the eligibility criteria and improved collaboration among nurses, anesthesiologists, and surgeons.<\/jats:p>","DOI":"10.3390\/jcm14134390","type":"journal-article","created":{"date-parts":[[2025,6,20]],"date-time":"2025-06-20T05:17:42Z","timestamp":1750396662000},"page":"4390","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Systemic Lidocaine Infusion for Acute Pain Management in a Surgical Intensive Care Unit: A Single-Arm Pilot Trial"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4915-3644","authenticated-orcid":false,"given":"Hina","family":"Faisal","sequence":"first","affiliation":[{"name":"Department of Surgery, Houston Methodist, Houston, TX 77030, USA"},{"name":"Center for Critical Care, Houston Methodist, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1005-2392","authenticated-orcid":false,"given":"Faisal N.","family":"Masud","sequence":"additional","affiliation":[{"name":"Center for Critical Care, Houston Methodist, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmoud M.","family":"Sabawi","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Houston Methodist, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nghi (Andy)","family":"Bui","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Houston Methodist, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara A.","family":"Butt","sequence":"additional","affiliation":[{"name":"Center for Health Data Science and Analytics, Houston Methodist, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9795-2435","authenticated-orcid":false,"given":"George E.","family":"Taffet","sequence":"additional","affiliation":[{"name":"Department of Medicine, Geriatric Division, Houston Methodist, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,6,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1308","DOI":"10.1097\/ALN.0b013e3181c0d4f0","article-title":"Pain Assessment is Associated with Decreased Duration of Mechanical Ventilation in the Intensive Care Unit: A Post Hoc Analysis of the DOLOREA Study","volume":"111","author":"Payen","year":"2009","journal-title":"Anesthesiology"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1286","DOI":"10.1001\/jamainternmed.2016.3298","article-title":"Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period","volume":"176","author":"Sun","year":"2016","journal-title":"JAMA Intern. Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"j5790","DOI":"10.1136\/bmj.j5790","article-title":"Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: Retrospective cohort study","volume":"360","author":"Brat","year":"2018","journal-title":"BMJ"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"e000192","DOI":"10.1136\/tsaco-2018-000192","article-title":"Multi-modal Analgesic Strategies for Trauma (MAST): Protocol for a pragmatic randomized trial","volume":"3","author":"Harvin","year":"2018","journal-title":"Trauma. Surg. Acute Care Open"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1007\/s12630-010-9407-0","article-title":"Perioperative intravenous lidocaine infusion for postoperative pain control: A meta-analysis of randomized controlled trials","volume":"58","author":"Vigneault","year":"2011","journal-title":"Can. J. Anaesth."},{"key":"ref_6","unstructured":"Lidocaine (2016). Clinical Pharmacology, Elsevier. Available online: http:\/\/www.clinicalkey.com\/pharmacology."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"858","DOI":"10.1097\/00000542-200009000-00038","article-title":"Local anesthetics and the inflammatory response: A new therapeutic indication?","volume":"93","author":"Hollmann","year":"2000","journal-title":"Anesthesiology"},{"key":"ref_8","first-page":"216","article-title":"Intravenous Lidocaine Infusion for the Management of Early Postoperative Pain: A Comprehensive Review of Controlled Trials","volume":"50","author":"Chu","year":"2020","journal-title":"Psychopharmacol. Bull."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Silva, A., Mour\u00e3o, J., and Vale, N. (2023). A Review of the Lidocaine in the Perioperative Period. J. Pers. Med., 13.","DOI":"10.3390\/jpm13121699"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"729","DOI":"10.1097\/ALN.0000000000001527","article-title":"Perioperative Use of Intravenous Lidocaine","volume":"126","author":"Dunn","year":"2017","journal-title":"Anesthesiology"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1097\/SLA.0b013e31805dac11","article-title":"Systemic lidocaine shortens length of hospital stay after colorectal surgery: A double-blinded, randomized, placebo-controlled trial","volume":"246","author":"Herroeder","year":"2007","journal-title":"Ann. Surg."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"932","DOI":"10.1097\/ALN.0b013e318297d4a5","article-title":"Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery","volume":"119","author":"Farag","year":"2013","journal-title":"Anesthesiology"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"676","DOI":"10.1007\/s12630-015-0333-z","article-title":"Does intravenous lidocaine infusion during video-assisted thoracoscopic surgery reduce postoperative analgesia? A randomized controlled study","volume":"62","author":"Slovack","year":"2015","journal-title":"Can. J. Anaesth."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1097\/00000542-199801000-00025","article-title":"Blockade of Na+ and K+ currents by local anesthetics in the dorsal horn neurons of the spinal cord","volume":"88","author":"Olschewski","year":"1998","journal-title":"Anesthesiology"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1016\/0014-2999(80)90529-4","article-title":"Inhibition by local anesthetics, phentolamine and propranolol of [3H]quinuclydinyl benzylate binding to central muscarinic receptors","volume":"68","author":"Aguilar","year":"1980","journal-title":"Eur. J. Pharmacol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1016\/S0014-2999(97)00182-9","article-title":"Mazindol and lidocaine are antinociceptives in the mouse formalin model: Involvement of dopamine receptor","volume":"330","author":"Bittencourt","year":"1997","journal-title":"Eur. J. Pharmacol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"68","DOI":"10.1016\/j.ejphar.2009.04.043","article-title":"Antinociceptive effects of systemic lidocaine: Involvement of the spinal glycinergic system","volume":"613","author":"Hermanns","year":"2009","journal-title":"Eur. J. Pharmacol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1111\/j.1399-6576.1993.tb03693.x","article-title":"Inhibitory effects of amide local anaesthetics on stimulus-induced human leukocyte metabolic activation, LTB4 release and IL-1 secretion in vitro","volume":"37","author":"Sinclair","year":"1993","journal-title":"Acta Anaesthesiol. Scand."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1138","DOI":"10.1111\/j.1399-6576.1996.tb05577.x","article-title":"Effect of lidocaine on histamine release and Ca2+ mobilization from mast cells and basophils","volume":"40","author":"Yanagi","year":"1996","journal-title":"Acta Anaesthesiol. Scand."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"260","DOI":"10.1016\/0005-2760(74)90055-1","article-title":"Effects of local anaesthetics on prostaglandin biosynthesis in vitro","volume":"360","author":"Kunze","year":"1974","journal-title":"Biochim. Biophys. Acta"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"265","DOI":"10.1111\/j.1399-6576.2006.00936.x","article-title":"Anti-inflammatory properties of local anesthetics and their present and potential clinical implications","volume":"50","author":"Cassuto","year":"2006","journal-title":"Acta Anaesthesiol. Scand."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"521","DOI":"10.1038\/clpt.1989.180","article-title":"Lidocaine metabolism in human liver microsomes by cytochrome P450IIIA4","volume":"46","author":"Bargetzi","year":"1989","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"830","DOI":"10.1002\/jcph.874","article-title":"Continuous Lidocaine Infusion as Adjunctive Analgesia in Intensive Care Unit Patients","volume":"57","author":"Mo","year":"2017","journal-title":"J. Clin. Pharmacol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1016\/0002-8703(82)90193-4","article-title":"Excessive serum lidocaine levels during maintenance infusions: Mechanisms and prevention","volume":"104","author":"Davison","year":"1982","journal-title":"Am. Heart J."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"947","DOI":"10.1016\/j.bja.2023.07.032","article-title":"Therapeutic efficacy of intravenous lidocaine infusion compared with thoracic epidural analgesia in major abdominal surgery: A noninferiority randomised clinical trial","volume":"131","year":"2023","journal-title":"Br. J. Anaesth."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1001\/jama.2024.23898","article-title":"Intravenous Lidocaine for Gut Function Recovery in Colonic Surgery: A Randomized Clinical Trial","volume":"333","author":"Paterson","year":"2025","journal-title":"JAMA"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1016\/j.bja.2023.03.026","article-title":"Efficacy of prolonged intravenous lidocaine infusion for postoperative movement-evoked pain following hepatectomy: A double-blinded, randomised, placebo-controlled trial","volume":"131","author":"Xu","year":"2023","journal-title":"Br. J. Anaesth."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1186\/s40814-016-0065-z","article-title":"Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials","volume":"2","author":"Thabane","year":"2016","journal-title":"Pilot Feasibility Stud."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1111\/anae.15270","article-title":"The use of intravenous lidocaine for postoperative pain and recovery: International consensus statement on efficacy and safety","volume":"76","author":"Foo","year":"2021","journal-title":"Anaesthesia"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"287","DOI":"10.1002\/pst.185","article-title":"The sample size of 12 per group rule of thumb for a pilot study","volume":"4","author":"Julious","year":"2005","journal-title":"Pharm. Stat."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"310","DOI":"10.1111\/j.1530-7085.2003.03034.x","article-title":"The numeric rating scale for clinical pain measurement: A ratio measure?","volume":"3","author":"Hartrick","year":"2003","journal-title":"Pain Pract."},{"key":"ref_32","unstructured":"American Pain Society (2008). Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain, American Pain Society. [6th ed.]."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"713","DOI":"10.1213\/ANE.0000000000006789","article-title":"Perioperative Patients with Hemodynamic Instability: Consensus Recommendations of the Anesthesia Patient Safety Foundation","volume":"138","author":"Scott","year":"2024","journal-title":"Anesth. Analg."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"697","DOI":"10.4172\/2155-6148.1000697","article-title":"Lidocaine Infusion: A Promising Therapeutic Approach for Chronic Pain","volume":"8","author":"Kandil","year":"2017","journal-title":"J. Anesth. Clin. Res."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"1250","DOI":"10.1002\/phar.2189","article-title":"Intravenous Lidocaine for Acute Pain: A Systematic Review","volume":"38","author":"Masic","year":"2018","journal-title":"Pharmacotherapy"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.1161\/01.CIR.50.6.1217","article-title":"The clinical pharmacology of lidocaine as an antiarrhythymic drug","volume":"50","author":"Collinsworth","year":"1974","journal-title":"Circulation"},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"1149","DOI":"10.2165\/10898560-000000000-00000","article-title":"Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: A systematic review of randomized controlled trials","volume":"70","author":"McCarthy","year":"2010","journal-title":"Drugs"},{"key":"ref_38","first-page":"e23310","article-title":"Lidocaine Infusion: An Antiarrhythmic with Neurologic Toxicities","volume":"14","author":"Daraz","year":"2022","journal-title":"Cureus"},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"499","DOI":"10.7326\/0003-4819-78-4-499","article-title":"Lidocaine pharmacokinetics in advanced heart failure, liver disease, and renal failure in humans","volume":"78","author":"Thomson","year":"1973","journal-title":"Ann. Intern. Med."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1016\/j.annemergmed.2017.12.014","article-title":"Safety and Efficacy of Intravenous Lidocaine for Pain Management in the Emergency Department: A Systematic Review","volume":"72","author":"Scherber","year":"2018","journal-title":"Ann. Emerg. Med."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1016\/j.pmn.2006.09.001","article-title":"Determination of clinically meaningful levels of pain reduction in patients experiencing acute postoperative pain","volume":"7","author":"Sloman","year":"2006","journal-title":"Pain Manag. Nurs."},{"key":"ref_42","doi-asserted-by":"crossref","unstructured":"Shanyinde, M., Pickering, R.M., and Weatherall, M. (2011). Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Med. Res. Methodol., 11.","DOI":"10.1186\/1471-2288-11-117"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/13\/4390\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T17:55:30Z","timestamp":1760032530000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/13\/4390"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,20]]},"references-count":42,"journal-issue":{"issue":"13","published-online":{"date-parts":[[2025,7]]}},"alternative-id":["jcm14134390"],"URL":"https:\/\/doi.org\/10.3390\/jcm14134390","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,20]]}}}