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Local Anesthetic

IV Lidocaine for Scoliosis (P-IVLT Trial)

Phase 3
Recruiting
Led By Gill Lauder, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with Idiopathic scoliosis
Undergoing single-stage posterior spinal instrumentation and fusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36 hours post-operatively
Awards & highlights

P-IVLT Trial Summary

This trial will compare two groups of children who have scoliosis surgery: one group will receive lidocaine and the other will not. Researchers will track how much pain medication each group needs and how well they recover.

Who is the study for?
This trial is for children with idiopathic scoliosis undergoing a specific back surgery (posterior spinal instrumentation and fusion) who are generally healthy to moderately ill pre-surgery (ASA I-III).Check my eligibility
What is being tested?
The study tests if IV lidocaine, given from the start of anesthesia up to 48 hours after surgery, can reduce morphine use and improve pain management post-operatively in children compared to saline solution.See study design
What are the potential side effects?
While not explicitly listed, potential side effects of IV lidocaine may include dizziness, sleepiness, changes in blood pressure or heart rate, numbness around the mouth or tongue. Morphine's side effects like nausea or breathing issues might be reduced.

P-IVLT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with a type of curved spine called idiopathic scoliosis.
Select...
You are having a surgery to fuse and stabilize your spine using a single-stage procedure.
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You have a mild to moderate medical condition, as classified by the American Society of Anesthesiologists.

P-IVLT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, 36 hours post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, 36 hours post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Mobililzation
Postoperative pain
Pain
+3 more

P-IVLT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intravenous lidocaineExperimental Treatment1 Intervention
1% preservative free lidocaine 10 mg/ml in 0.9% NaCl
Group II: Intravenous saline controlPlacebo Group1 Intervention
0.9% sodium chloride, also known as normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,407 Previous Clinical Trials
1,766,501 Total Patients Enrolled
8 Trials studying Scoliosis
502 Patients Enrolled for Scoliosis
Gill Lauder, MDPrincipal InvestigatorUniversity of British Columbia

Media Library

Lidocaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04069169 — Phase 3
Scoliosis Research Study Groups: Intravenous lidocaine, Intravenous saline control
Scoliosis Clinical Trial 2023: Lidocaine Highlights & Side Effects. Trial Name: NCT04069169 — Phase 3
Lidocaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04069169 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project allow volunteers who are elderly?

"This clinical study is welcoming participants that are between 10 to 19 years old."

Answered by AI

What range of ailments does Lidocaine address?

"Lidocaine is often used to treat cervical syndrome, however it can also be used to manage minor burns, osteoporosis, and pain related to transplantation."

Answered by AI

Are people with the specific set of symptoms required for this trial still able to enroll?

"The clinical trial is still recruiting patients, as of the latest update on October 4th, 2021. The original posting was on December 18th, 2019."

Answered by AI

Has Lidocaine been federally cleared for use?

"Lidocaine is estimated to be a 3 on a scale of 1 to 3 in terms of safety. This is due to the fact that it is a Phase 3 trial, and therefore has both some supporting data for efficacy as well as multiple rounds of data supporting safety."

Answered by AI

What does the scientific research say about Lidocaine's medical benefits?

"As of now, there are a total of 135 clinical trials studying Lidocaine with 34 of them being Phase 3 trials. Even though the majority of these tests are based in Calgary, Alberta, there are 1,083 total locations running these sorts of trials."

Answered by AI

What are the medical requirements for volunteers in this trial?

"Up to 48 patients that have undergone anesthesia and have a recovery period aged 10 to 19 can be admitted. The most crucial requirement for applicants is that they must have had single-stage posterior spinal instrumentation and fusion."

Answered by AI
~9 spots leftby Mar 2025