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IV Lidocaine for Scoliosis (P-IVLT Trial)
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.
P-IVLT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowP-IVLT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.P-IVLT Trial Design
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Who is running the clinical trial?
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- You have a mild to moderate medical condition, as classified by the American Society of Anesthesiologists.You have been diagnosed with a type of curved spine called idiopathic scoliosis.You are having a surgery to fuse and stabilize your spine using a single-stage procedure.
- Group 1: Intravenous lidocaine
- Group 2: Intravenous saline control
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research project allow volunteers who are elderly?
"This clinical study is welcoming participants that are between 10 to 19 years old."
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."
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."
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."
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."
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."
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