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

NCT07552766 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00000497
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fracture Arm; Fracture Elbow; Fracture Fixation; Fracture Fixation, Internal; Fracture Forearm; Fracture Distal Radius; Fracture Closed of Lower End of Forearm, Unspecified

Outcome Measures

Primary Outcomes (1)

• Total perioperative opioid consumption

  Determine the effect of IVLI on intraoperative and postoperative opioid consumption in pediatric patients undergoing orthopedic surgery for long bone fractures of the upper extremity

  60 minutes after patient arrival to post-anesthesia care unit (PACU)

Secondary Outcomes (3)

• Postoperative pain scores

  30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.

• Rescue Anti-Emetic Use

  Duration of Phase 1 PACU length of stay

• Infusion and Surgical Length

  60 minutes after patient arrives in post-anesthesia care unit (PACU)

Study Arms (2)

Patients receiving lidocaine infusion

EXPERIMENTAL

Drug: Lidocaine Infusion

Patients receiving placebo

PLACEBO COMPARATOR

Other: Standard of Care (SOC)

Interventions

Lidocaine Infusion DRUG

Patients will be randomized to receive either lidocaine infusion or placebo intraoperatively. Perioperative opioid requirements will be compared between the two groups.

Patients receiving lidocaine infusion

Standard of Care (SOC) OTHER

Standard of care

Patients receiving placebo

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Hospital

Wilmington, Delaware, 19803, United States

Location

Related Publications (12)

• 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 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.

  PMID: 39076006 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.

  PMID: 39365287 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.

  PMID: 33397287 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.

  PMID: 34036532 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.

  PMID: 33633427 BACKGROUND

• 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 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.

  PMID: 14715049 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.

  PMID: 40021547 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.

  PMID: 6863582 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.

  PMID: 27199310 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.

  PMID: 34516466 BACKGROUND

MeSH Terms

Conditions

Elbow Fractures; Wrist Fractures

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Wrist Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Angela Snow, MD

CONTACT

302-824-1792; angela.snow@nemours.org

Isabela Santiago, BS

CONTACT

302-577-0126; isabela.santiago@nemours.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthesiologist

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)