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RECRUITING
NCT07552766
PHASE4

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

Sponsor: Nemours Children's Clinic

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

3 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-06-24

Completion Date

2029-07

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DRUG

Lidocaine Infusion

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

OTHER

Standard of Care (SOC)

Standard of care

Locations (1)

Nemours Children's Hospital

Wilmington, Delaware, United States