Recruiting

IV Lidocaine

Sponsor:

Nemours Children's Clinic

Code:

NCT07552766

Conditions

Fracture Arm

Fracture Closed of Lower End of Forearm, Unspecified

Fracture Elbow

Fracture Fixation

Fracture Fixation, Internal

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Interventions

Lidocaine Infusion

Standard of Care (SOC)

Study Details

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.

Conditions

Fracture Arm

Fracture Closed of Lower End of Forearm, Unspecified

Fracture Elbow

Fracture Fixation

Fracture Fixation, Internal

Study ID

NCT07552766

Start date

Jun 24, 2026

Status verified date

Apr, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients receiving lidocaine infusion

placebo comparator: Patients receiving placebo

Interventions

Lidocaine Infusion

Patients 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)

Standard of care

Primary outcome measure

  • Total perioperative opioid consumption [ Time Frame: 60 minutes after patient arrival to post-anesthesia care unit (PACU) ]

Central Contacts and Locations

Locations

Nemours Children's Hospital

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Principal Investigator:

Angela Snow, MR

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Jul 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-07-06.