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New treatment option for Fracture Arm
Official title A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
ClinicalTrials.gov ID: NCT07552766
What this study is testing
What is Lidocaine Infusion?
Lidocaine Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for fracture arm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- 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...
You likely can't join if
- Children \ 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
See the full eligibility 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
- Children \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Wilmington, Delaware, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wilmington, Delaware, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.