IV Lidocaine for Post-Operative Pain in Pediatric Spinal Conditions

(PEDS LIDO Trial)

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well intravenous (IV) lidocaine manages pain after spinal surgery in teens with scoliosis, a condition where the spine curves sideways. It examines whether lidocaine can reduce the need for opioids, which are strong painkillers, and aid in faster recovery after surgery. The trial includes two groups: one receiving lidocaine and the other a placebo (a treatment with no active drug). Teens diagnosed with scoliosis who need spinal fusion surgery might be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how lidocaine can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for IV lidocaine?

Research has shown that intravenous lidocaine is generally safe for managing post-surgical pain in children. One study suggested that lidocaine infusions are a safe option for pain relief in this group. However, improper use can lead to serious side effects, though such cases are rare.

Another study examined lidocaine use in children and found it effective and well-tolerated. These findings support its safe use in similar situations.

As this trial is in a later phase, earlier studies have already tested the treatment for safety, further supporting its use here. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for post-operative pain in pediatric spinal conditions rely on opioids, which can have significant side effects and risk of dependency. However, IV lidocaine is unique because it acts as a local anesthetic, blocking pain signals without the downsides of opioids. Researchers are excited about IV lidocaine because it can be administered intravenously, providing rapid pain relief during and after surgery, potentially reducing the need for opioid medications. This approach not only promises effective pain management but also enhances recovery and overall patient safety.

What evidence suggests that IV lidocaine might be an effective treatment for post-operative pain in pediatric spinal conditions?

Research shows that IV (intravenous) lidocaine, which participants in this trial may receive, can help manage post-surgical pain. Studies have found it significantly lowers pain levels compared to a placebo. For instance, one study noted that IV lidocaine noticeably reduced pain two hours after surgery. Additionally, a review of several studies found that lidocaine reduced the need for extra pain medication. However, some studies suggest it might not be effective for all surgeries, such as spine surgeries. Overall, while some evidence supports its use, results can vary depending on the type of surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Scott Luhmann, MD

Principal Investigator

St. Louis Children's Hospital

Are You a Good Fit for This Trial?

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34196720/

Perioperative Intravenous Lidocaine Infusion for Post- ... Intravenous lidocaine administration was associated with significantly reduced visual analogue pain scores at two MD= -1.13, four-six MD =-0.79 ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pan.15015

Perioperative intravenous lignocaine for pediatric ... The meta-analysis of seven studies concluded that perioperative intravenous lignocaine bolus followed by an infusion significantly reduced the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666548421000317

Intravenous lidocaine in spine surgery: A meta-analysis of ... Our results indicated that current literature does not support the use of intravenous lidocaine as an adjunctive measure of pain management after spine surgery.

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05010148

A Clinical Trial of Intravenous Lidocaine After Spinal Surgery ... A postoperative intravenous infusion of lidocaine, known to improve pain control in other contexts, can decrease the risk of postoperative delirium.

5. asja.springeropen.com asja.springeropen.com/articles/10.1186/s42077-023-00361-3

The impact of intraoperative intravenous lidocaine infusion on ... When compared to placebo, lidocaine infusion significantly reduced the postoperative pain scores, as well as the entire dose of intraoperative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6397014/

Safety and Tolerability of Lidocaine Infusions as a ... In conclusion, our study suggests that lidocaine infusions appear to be a safe option for a multimodal postoperative pain management in the pediatric ...

7. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15270

The use of intravenous lidocaine for postoperative pain and ... Intravenous lidocaine is used widely for its effect on postoperative pain and recovery but it can be, and has been, fatal when used inappropriately and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8609473/

Lidocaine Infusions for Pain Management in Pediatrics - PMC Here, we review and evaluate published data reflecting the use of lidocaine continuous infusions for pain management in the pediatric population.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pan.14608

Perioperative intravenous lidocaine use in children - Heath In the spinal surgery patients, postoperative endocannabinoid levels, which lead to pain control, were shown to be elevated in the lidocaine ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03893318

Study Details | NCT03893318 | IV Lidocaine in Pediatric AIS This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the ...