A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements

Официальное название

A Prospective, Randomized, Double-blind Trial of the Impact of Intraoperative Intravenous Lidocaine Infusion on Total Opioid Requirements in Children Undergoing Surgical Fixation of Upper Extremity Long Bone Fractures Under General Anesthesia

Обзор

This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Ninety pediatric patients, ages 3-18 will be enrolled and randomized 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery. All participants will receive standardized anesthesia care and postoperative pain management. Opioid consumption and pain scores will be measured intraoperatively and throughout the postoperative recovery, with the primary outcome focused on total opioid use 60 minutes after arrival to the post-anesthesia care unit (PACU). Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use and the relationship between infusion duration and outcomes. Patients will be closely monitored for signs of local anesthetic systemic toxicity and other adverse events. The goal of this study is to determine whether IV lidocaine is an effective opioid-sparing adjunct in pediatric orthopedic surgery and to support safer, multimodal analgesia strategies.

Вмешательства

• Препарат Lidocaine Infusion
  Patients will be randomized to receive either lidocaine infusion or placebo intraoperatively. Perioperative opioid requirements will be compared between the two groups.
• Другое Standard of Care (SOC)
  Standard of care

Первичные конечные точки

• Total perioperative opioid consumption [Срок оценки: 60 minutes after patient arrival to post-anesthesia care unit (PACU)]

Вторичные конечные точки (3)

• Postoperative pain scores [Срок оценки: 30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.]
• Rescue Anti-Emetic Use [Срок оценки: Duration of Phase 1 PACU length of stay]
• Infusion and Surgical Length [Срок оценки: 60 minutes after patient arrives in post-anesthesia care unit (PACU)]

Критерии участия

Критерии включения

• Patients aged 3-18 years
• Patients > 10 kg
• Patients who present to Nemours Children's Hospital - Delaware Valley (NCH-DE) for surgical fixation of upper extremity fractures from distal humerus to distal radius

Критерии исключения

• Children < 3 years or > 18 years
• Patients with allergy to local anesthetics
• Patients who are eligible for an receive a peripheral nerve block
• Patients with multi-trauma or open fractures
• Patients with previous history of seizure disorder
• Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment
• Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole)
• Patients with chronic kidney or liver dysfunction
• Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists)
• Patients with positive pregnancy test prior to surgery or nursing mothers
• Patients who parents decline enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Nemours Children's Hospital — Wilmington

Публикации

• Heath C, Hii J, Thalayasingam P, von Ungern-Sternberg BS, Sommerfield D. Perioperative intravenous lidocaine use in children. Paediatr Anaesth. 2023 May;33(5):336-346. doi: 10.1111/pan.14608. Epub 2022 Dec 4. PMID 36424875
• Pardessus P, Loiselle M, Brouns K, Horlin AL, Bruneau B, Maroun Y, Lagarde M, Deliere M, Julien-Marsollier F, Dahmani S. Intravenous lidocaine for postoperative analgesia management in paediatrics: A systematic review with meta-analysis of published studies. Eur J Anaesthesiol. 2024 Nov 1;41(11):856-864. doi: 10.1097/EJA.0000000000002046. Epub 2024 Jul 29. PMID 39076006
• Gupta A, Ashok V. Perioperative intravenous lignocaine for pediatric postoperative pain-A systematic review and meta-analysis. Paediatr Anaesth. 2025 Jan;35(1):25-32. doi: 10.1111/pan.15015. Epub 2024 Oct 4. PMID 39365287
• Kaszynski M, Lewandowska D, Sawicki P, Wojcieszak P, Pagowska-Klimek I. Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Jan 5;21(1):2. doi: 10.1186/s12871-020-01218-0. PMID 33397287
• Hall EA, Sauer HE, Davis MS, Anghelescu DL. Lidocaine Infusions for Pain Management in Pediatrics. Paediatr Drugs. 2021 Jul;23(4):349-359. doi: 10.1007/s40272-021-00454-2. Epub 2021 May 26. PMID 34036532
• Chu R, Umukoro N, Greer T, Roberts J, Adekoya P, Odonkor CA, Hagedorn JM, Olatoye D, Urits I, Orhurhu MS, Umukoro P, Viswanath O, Hasoon J, Kaye AD, Orhurhu V. Intravenous Lidocaine Infusion for the Management of Early Postoperative Pain: A Comprehensive Review of Controlled Trials. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):216-259. doi: 10.64719/pb.4391. PMID 33633427
• Finholt DA, Stirt JA, DiFazio CA, Moscicki JC. Lidocaine pharmacokinetics in children during general anesthesia. Anesth Analg. 1986 Mar;65(3):279-82. PMID 3954094
• Mazoit JX, Dalens BJ. Pharmacokinetics of local anaesthetics in infants and children. Clin Pharmacokinet. 2004;43(1):17-32. doi: 10.2165/00003088-200443010-00002. PMID 14715049

Идентификаторы

NCT: NCT07552766 · STUDY00000497

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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