Postoperative and Chronic Pain Genetic Spine Surgery Study

Running, not enrolling

Conditions studied: Scoliosis, Kyphosis, Kyphoscoliosis

In brief

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.

Key facts

Study ID

NCT02998138

Run by

Children's Hospital Medical Center, Cincinnati

People needed

880

Starts

2016-12-01

Expected to finish

2026-12-01

Last updated by the study team

2025-09-22

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 10 to 18, inclusive, years of age
• Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis
• Scheduled for spine fusion.

You may not qualify if…

• 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.
• Developmental delay
• Body Mass Index ≥ 30
• 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.
• Severe lung disease such as cystic fibrosis, pulmonary fibrosis, pneumonia within the last month
• History of seizures currently treated on medication (patients off medication and seizure free for greater than one year may be included)
• Other known genetic diseases including but not limited to Ehlers Danlos, Downs' etc.
• History of Obstructive sleep apnea by history (pauses during sleep, significant snoring, use of CPAP)

Where it is running

• Stanford University Hospital — Stanford, California, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Duke Children's Hospital — Durham, North Carolina, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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