NCT07552766 A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
| NCT ID | NCT07552766 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nemours Children's Clinic |
| Condition | Fracture Arm |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-06-24 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2026-06-24 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07552766 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Fracture Arm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07552766 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07552766 currently recruiting?
Yes, NCT07552766 is actively recruiting participants. Contact the research team at angela.snow@nemours.org for enrollment information.
Where is the NCT07552766 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT07552766 clinical trial?
NCT07552766 is sponsored by Nemours Children's Clinic. The trial plans to enroll 90 participants.