Lidocaine for Scoliosis

BC Children's Hospital - Department of Anesthesia, Vancouver, Canada
Scoliosis+1 More ConditionsLidocaine - Drug
10 - 19
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Scoliosis
  • Post-Anesthesia Recovery Period

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

0 Primary · 6 Secondary · Reporting Duration: 12, 24, 36 hours post-operatively

Hour 36
Total morphine utilization
Hour 48
Postoperative pain
Day 5
Urinary incontinence
Hour 48

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

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.

Trial Design

2 Treatment Groups

Intravenous lidocaine
1 of 2
Intravenous saline control
1 of 2

Experimental Treatment

Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Lidocaine · Has Placebo Group · Phase 3

Intravenous lidocaine
Experimental Group · 1 Intervention: Lidocaine · Intervention Types: Drug
Intravenous saline control
PlaceboComparator Group · 1 Intervention: Saline Solution · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12, 24, 36 hours post-operatively

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,354 Previous Clinical Trials
1,564,811 Total Patients Enrolled
7 Trials studying Scoliosis
398 Patients Enrolled for Scoliosis
Gill Lauder, MDPrincipal InvestigatorUniversity of British Columbia

Eligibility Criteria

Age 10 - 19 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
You have a mild to moderate medical condition, as classified by the American Society of Anesthesiologists.

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.