Lidocaine Infusion for Broken Arm

IS
AS
Overseen ByAngela Snow, MD
Stay on Your Current MedsYou can continue your current medications while participating
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 3 and 18 years old.
I weigh more than 10 kilograms.
I am having surgery at Nemours for a fracture in my arm between the elbow and wrist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intraoperative intravenous lidocaine infusion or placebo during surgery

Intraoperative period
1 visit (in-person)

Postoperative Monitoring

Opioid consumption and pain scores are measured intraoperatively and throughout the postoperative recovery

60 minutes after arrival to PACU
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid use

PACU stay duration

What Are the Treatments Tested in This Trial?

Interventions

  • Lidocaine Infusion

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Patients receiving lidocaine infusionExperimental Treatment1 Intervention
Group II: Patients receiving placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials
128
Recruited
18,000+