A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements

July 1, 2026 updated by: Angela Snow, Nemours Children's Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours Children's Hospital
        • Contact:
        • Principal Investigator:
          • Angela Snow, MR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Patients receiving placebo
Other: Standard of Care (SOC)
Standard of care
Experimental: Patients receiving lidocaine infusion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 minutes after patient arrival to post-anesthesia care unit (PACU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.
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.
Duration of Phase 1 PACU length of stay
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.
60 minutes after patient arrives in post-anesthesia care unit (PACU)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000497

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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