Postoperative and Chronic Pain Genetic Spine Surgery Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 10 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Children aged 10 to 18, inclusive, years of age. 2. Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis. 3. Scheduled for spine fusion.

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)

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital Medical Center, Cincinnati
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vidya Chidambaran, MD
Principal Investigator Affiliation Children's Hospital Medical Center, Cincinnati
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Enrolling by invitation
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Scoliosis, Kyphosis, Kyphoscoliosis
Additional Details

Safe and effective analgesia is an important unmet medical need in children. Despite efforts to promote non-pharmacologic interventions, drug treatment remains the standard of care for children experiencing severe pain following surgery. Inadequate pain relief after invasive surgery, and side effects from analgesics such as morphine occur frequently in up to 50% of children. A study of patient controlled analgesia (PCA) morphine use after spine surgery in adolescents observed a 45% incidence of postoperative nausea and vomiting and 7% incidence of respiratory depression. Presently, evidence-based dosing guidelines for opioid therapy have not been ascertained in the pediatric patient population, and remains a trial and error method. Despite aggressive pain management after spine surgery, findings showed that neither children's pain nor their analgesic use diminished significantly over time. As such, there is a critical knowledge gap in the medical literature that significantly impacts the pediatric pain management. Moreover, chronic postsurgical pain (CPSP, defined as pain attributable to the surgical procedure lasting for more than 2 months after surgery critically impacts 13-30% of children having surgery, and leads to chronic pain as adults imposing extraordinary annual costs on the health care system ($560-635 billion). It has been recently shown that pain unpleasantness predicts the transition from acute to moderate/severe persistent post-surgical pain, whereas anxiety sensitivity predicts the maintenance of moderate/severe post-surgical pain from 6 to 12 months after surgery. Spine fusion in adolescents is a particularly painful surgery with 15% incidence of pain even 5 years after surgery, and hence will serve as a good surgical model to evaluate the behavioral and genetic predictors of chronic postoperative pain. In recognition of this therapeutic challenge the investigators plan to evaluate the determinants of inter-individual differences in opioid analgesic responsiveness, adverse effects, pain perception and predictors of chronic postoperative pain in children.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University Hospital, Stanford, California



Stanford University Hospital

Stanford, California, 94305

Johns Hopkins Hospital, Baltimore, Maryland



Johns Hopkins Hospital

Baltimore, Maryland, 21205

University of Mississippi Medical Center, Jackson, Mississippi



University of Mississippi Medical Center

Jackson, Mississippi, 39216

Duke Children's Hospital, Durham, North Carolina



Duke Children's Hospital

Durham, North Carolina, 27710

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania



The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104