IV Lidocaine for Post-Operative Pain in Pediatric Spinal Conditions
(PEDS LIDO Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intravenous lidocaine or saline placebo during and after posterior spinal fusion for AIS
Follow-up
Participants are monitored for opioid consumption and recovery using PROMIS-CAT assessments
Extended Follow-up
Participants are assessed for opioid consumption and recovery at three months postoperatively
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?
2
Treatment groups
Experimental Treatment
Placebo Group
will receive intravenous lidocaine during and after posterior spinal fusion for AIS
will receive saline placebo during and after surgery.
IV lidocaine is already approved in United States, European Union, Canada for the following indications:
- Local anesthesia
- Ventricular tachycardia
- Ventricular fibrillation
- Postoperative pain control
- Local anesthesia
- Ventricular tachycardia
- Ventricular fibrillation
- Postoperative pain control
- Local anesthesia
- Ventricular tachycardia
- Ventricular fibrillation
- Postoperative pain control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Citations
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 ...
Perioperative intravenous lignocaine for pediatric ...
The meta-analysis of seven studies concluded that perioperative intravenous lignocaine bolus followed by an infusion significantly reduced the ...
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.
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.
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 ...
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 ...
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associationofanaesthetists-publications.onlinelibrary.wiley.com
associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15270The 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 ...
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.
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 ...
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 ...
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