RecruitingPhase 4NCT07552766

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

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


Sponsor

Nemours Children's Clinic

Enrollment

90 participants

Start Date

Jun 24, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lidocaine Infusion and Standard of Care (SOC) for people with fracture arm, fracture closed of lower end of forearm, unspecified, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLidocaine Infusion

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

OTHERStandard of Care (SOC)

Standard of care


Locations(1)

Nemours Children's Hospital

Wilmington, Delaware, United States

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NCT07552766


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