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NCT Number: 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

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.

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Key information

Conditions

Fracture Arm Arm Injuries Elbow Fractures Elbow Injuries Fracture Closed of Lower End of Forearm, Unspecified Fracture Distal Radius Fracture Elbow Fracture Fixation Fracture Fixation, Internal Fracture Forearm Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nemours Children's Hospital

Wilmington, Delaware, 19803, United States

Location status: Recruiting

Location contact

Angela Snow, MR

PRINCIPAL_INVESTIGATOR

Isabela Santiago

CONTACT

[email protected]

302-577-0126

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine infusion

Drug

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)

Other

Standard of care

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative pain scores

    Time frame: 30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.

    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.

  2. Rescue Anti-Emetic Use

    Time frame: Duration of Phase 1 PACU length of stay

    Assess the effect of IVLI on rescue anti-emetic use and Phase 1 PACU length of stay.

  3. Infusion and Surgical Length

    Time frame: 60 minutes after patient arrives in post-anesthesia care unit (PACU)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Snow, MD

CONTACT

[email protected]

302-824-1792

Isabela Santiago, BS

CONTACT

[email protected]

302-577-0126

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 27, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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