IV Lidocaine for Post-Operative Pain in Pediatric Spinal Conditions

(PEDS LIDO Trial)

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Washington University School of Medicine

Disqualifiers: Sepsis, Malignancy, Heart block, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: In-hospital stay

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a medication can help manage pain after spinal surgery in teens with scoliosis. The goal is to reduce the need for stronger painkillers by using this medication, which numbs tissues and reduces pain. This medication has been studied for its potential to reduce pain and the need for stronger painkillers in various types of surgeries, including spine surgeries.

Research Team

Scott Luhmann, MD

Principal Investigator

St. Louis Children's Hospital

Eligibility Criteria

This trial is for adolescents aged 12-18 with idiopathic scoliosis needing spinal fusion surgery. They must have a guardian to consent and be able to complete surveys. Excluded are those outside the age range, with certain medical conditions like infections, cancer, seizure disorders or heart issues, involved in other trials, or unable to understand English without a translator.

Inclusion Criteria

My parent or guardian can give consent for me to join the study.

I am between 12 and 18 years old.

I have scoliosis and need surgery to correct my spine.

Exclusion Criteria

I am able to understand and consent to the surgery or study on my own.

I have had seizures in the past or have a seizure disorder.

Ward of the State children

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous lidocaine or saline placebo during and after posterior spinal fusion for AIS

In-hospital stay

Follow-up

Participants are monitored for opioid consumption and recovery using PROMIS-CAT assessments

6 weeks

Extended Follow-up

Participants are assessed for opioid consumption and recovery at three months postoperatively

3 months

Treatment Details

Interventions

• IV lidocaine
• Placebos

Trial Overview The study tests if IV lidocaine can manage post-surgery pain for spine fusion patients better than a placebo. It's randomized and triple-blind so neither doctors nor participants know who gets real medicine vs placebo. The focus is on reducing opioid use after surgery and speeding up recovery.

Participant Groups

Group I: Study Group Experimental Treatment 1 Intervention

will receive intravenous lidocaine during and after posterior spinal fusion for AIS

Group II: Control Group Placebo Group 1 Intervention

will receive saline placebo during and after surgery.

IV lidocaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lidocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Postoperative pain control

Approved in European Union as Lignocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Postoperative pain control

Approved in Canada as Lidocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Postoperative pain control

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+