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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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Delaware
Nemours Children's Hospital
RECRUITING
Wilmington
Contact Information
Primary
Angela Snow, MD
angela.snow@nemours.org
302-824-1792
Backup
Isabela Santiago, BS
isabela.santiago@nemours.org
302-577-0126
Time Frame
Start Date: 2026-06-24
Estimated Completion Date: 2029-07
Participants
Target number of participants: 90
Treatments
Experimental: Patients receiving lidocaine infusion
Placebo_comparator: Patients receiving placebo
Related Therapeutic Areas
Sponsors
Leads: Nemours Children's Clinic

This content was sourced from clinicaltrials.gov