Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Cor… (NCT04697498) | Clinical Trial Compass
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Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
Ukraine150 participantsStarted 2020-12-16
Plain-language summary
Improving the anesthesiology management for surgical correction of spinal deformations with introducing the diagnostic methods and treatment strategy of acute pain, preventing the evolution of chronic pain. Development and implementation in clinical practice perioperative intensive care protocols for surgical correction of spinal deformities.
Who can participate
Age range
12 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed consent of the patient or his legal representatives to participate the study.
. Spinal deformity that requires surgical correction.
. No known allergies to local anaesthetics.
. Negative intradermal test for sensitivity to local anaesthetics.
Exclusion criteria
. Refusal of the patient or his legal representatives to participate the study
. Diabetes mellitus, known allergy to local anaesthetics
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in The Numeric Pain Rating Scale
Timeframe: On the 1st, 2rd and 3th day after surgery
2
Duration of hospitalization
Timeframe: Through study completion, an average of 1 year
3
Time of weaning the patient from mechanical ventilation