NCT07552766 · Nemours Children's Clinic
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
What this study is about
This study is a forward-looking, randomly assigned, where neither patients nor doctors know which treatment is given clinical trial evaluating whether intraoperative given through a vein (IV) 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.
View original scientific description
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.
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
Primary outcome measures
Total perioperative opioid consumption
Time frame: 60 minutes after patient arrival to post-anesthesia care unit (PACU)
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Patients with previous history of seizure disorder
- Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment
- Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole)
- Patients with chronic kidney or liver dysfunction
- Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists)
- Patients with positive pregnancy test prior to surgery or nursing mothers
- Patients who parents decline enrollment
Where
- Wilmington, Delaware
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations