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

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Nemours Children's Clinic
Study ID
NCT07552766
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Fracture Arm
  • Fracture Closed of Lower End of Forearm, Unspecified
  • Fracture Distal Radius
  • Fracture Elbow
  • Fracture Fixation
  • Fracture Fixation, Internal
  • Fracture Forearm

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients receiving lidocaine infusion
  • Placebo Comparator: Patients receiving placebo

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's HospitalWilmingtonDelaware19803
Isabela Santiago
[email protected]
302-577-0126
Angela Snow, MR (PRINCIPAL_INVESTIGATOR)

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By research site
Nemours Children's Hospital· Wilmington, DE

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