Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Active, not recruitingNCT02998138
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Multi-center Study of Genomic and Psychological Factors Affecting Postoperative and Chronic Pain in Children Undergoing Invasive (Spine) Surgery
- Conditions
- Scoliosis
- Kyphosis
- Kyphoscoliosis
- Pectus Excavatum
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Start date
- 2016-12
- Primary completion
- 2025-12
- Sex
- All
- Age range
- from 10 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Children aged 10 and aove 2. Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis, scheduled for spine fusion. 3. Diagnosis of pectus excavatum, scheduled to undergo Nuss procedures Exclusion Criteria: 1. Patients on chronic pain medication (opioid use over 6 months prior to surgery) 2. Pregnant or breastfeeding females. 3. Children with a history of or active renal or liver disease. 4. Non-English speaking patients. 5. Developmental delay 6. Body Mass Index ≥ 30 7. Currently taking tricyclic, selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI) class of medications (within the last month) 8. 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. 9. Severe lung disease such as cystic fibrosis, pulmonary fibrosis, pneumonia within the last month 10. History of seizures currently treated on medication (patients off medication and seizure free for greater than one year may be included) 11. Other known genetic diseases including but not limited to Ehlers Danlos, Downs' etc. 12. History of Obstructive sleep apnea by history (pauses during sleep, significant snoring, use of CPAP)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02998138