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.
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
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
Parallel
Lidocaine Infusion
DrugPatients will be randomized to receive either lidocaine infusion or placebo intraoperatively. Perioperative opioid requirements will be compared between the two groups.
Standard of Care (SOC)
Other interventionStandard of care
Total perioperative opioid consumption
Determine the effect of IVLI on intraoperative and postoperative opioid consumption in pediatric patients undergoing orthopedic surgery for long bone fractures of the upper extremity
Postoperative pain scores
The maximum postoperative pain scores in patients who received IVLI will be equivalent or less than patients who received placebo in PACU at 30, 60, and 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.
Rescue Anti-Emetic Use
Assess the effect of IVLI on rescue anti-emetic use and Phase 1 PACU length of stay.
Infusion and Surgical Length
Evaluate if the infusion time of IVLI impacts post-operative opioid consumption and post- operative pain scores. Hypothesis: Patients who receive IVLI for \> 2 hours will have lower post- operative opioid requirements and post-operative pain scores than patients who receive the infusion for \< 2 hours.
Click on the lead sponsor to view all of their trials.
