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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified, Fracture Elbow, Fracture Fixation, Fracture Fixation, Internal, Fracture Forearm, Fracture Distal Radius

In brief

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.

Key facts

Study ID

NCT07552766

Run by

Nemours Children's Clinic

People needed

90

Starts

2026-06-24

Expected to finish

2029-07-01

Last updated by the study team

2026-07-06

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Nemours Children's Hospital — Wilmington, Delaware, United States (enrolling)

Full record on ClinicalTrials.gov

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