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

Summary

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.

Timeline

Start

2026-06-24

Primary completion

2028-12

Completion

2029-07

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Finholt DA, Stirt JA, DiFazio CA, Moscicki JC. Lidocaine pharmacokinetics in children during general anesthesia. Anesth Analg. 1986 Mar;65(3):279-82.
• Background 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.
• Background Foong KW, Loh PS, Chaw SH, Lo YL. Population Pharmacokinetics of IV Lidocaine and its Metabolites in Adult Surgical Patients. Pharm Res. 2025 Mar;42(3):451-473. doi: 10.1007/s11095-025-03835-1. Epub 2025 Feb 28.
• Background Ochs HR, Knuchel M, Abernethy DR, Greenblatt DJ. Dose-independent pharmacokinetics of intravenous lidocaine in humans. J Clin Pharmacol. 1983 Apr;23(4):186-8. doi: 10.1002/j.1552-4604.1983.tb02723.x. No abstract available.
• Background Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.
• Background Keil LG, Sullivan MH, Dadoo S, Stillwagon MR, Vergun AD. How Much Opioid Do Kids Actually Need? A Prospective Study of Analgesic Prescribing and Postdischarge Opioid Use Among Pediatric Patients With Operative Fractures. J Pediatr Orthop. 2021 Nov-Dec 01;41(10):e871-e876. doi: 10.1097/BPO.0000000000001965.

Drugs

Indications

No indication recorded.