Postoperative and Chronic Pain Genetic Spine Surgery Study (NCT02998138) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Postoperative and Chronic Pain Genetic Spine Surgery Study
United States880 participantsStarted 2016-12
Plain-language summary
This will be an open label, prospective study to determine the association between specific genotypes, epigenetics and behavioral factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic and side effect responses to perioperative opioids, chronic postoperative pain and gene expression in adolescents following major spine surgery.
Who can participate
Age range
10 Years – 18 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
. Children aged 10 to 18, inclusive, years of age
. Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis
. Scheduled for spine fusion.
Exclusion criteria
. Patients on chronic pain medication (opioid use over 6 months prior to surgery)
. Pregnant or breastfeeding females.
. Children with a history of or active renal or liver disease.
. Non-English speaking patients.
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
Numeric rating scale (NRS) pain scores
Timeframe: Data will be collected for 48 hours postoperatively
2
Occurrences of respiratory depression
Timeframe: Data will be collected for 48 hours postoperatively
3
Occurrences of post-operative nausea/vomiting (PONV)
Timeframe: Data will be collected for 48 hours postoperatively
Trial details
NCT IDNCT02998138
SponsorChildren's Hospital Medical Center, Cincinnati
. Currently taking tricyclic, selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI) class of medications (within the last month)
. Cardiac conditions including, but not limited to, cyanotic heart disease, Hypoplastic Left Ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki Disease, cardiomyopathies. Patients with asymptomatic valvular lesions or defects may be included.