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ScoliosisNCT02998138

Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study

An observational study of Scoliosis and Kyphosis, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
Scoliosis, Kyphosis, Kyphoscoliosis
How many people
880 participants
Where
5 sitesUnited States
Study dates
Dec 2016to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The investigators will recruit a total of 880 subjects over the study period to acquire the data necessary to derive a predictive model matching phenotype to genotype. They will be recruited from the population of children ages 10 and above, inclusive, years scheduled for spinal surgical procedures/Nuss procedures.

Who may be able to join

  • Children aged 10 and aove
  • Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis, scheduled for spine fusion.
  • Diagnosis of pectus excavatum, scheduled to undergo Nuss procedures

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205

  • Duke Children's Hospital

    Durham, North Carolina, 27710

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Stanford University Hospital

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Multi-center Study of Genomic and Psychological Factors Affecting Postoperative and Chronic Pain in Children Undergoing Invasive (Spine) Surgery

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.

Read the detailed description

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. In addition, pectus procedures are painful and will also be included in the study, alongwith analgesia modalities. Secondary analyses will include analgesic associations with study outcomes.

Keywords
Chronic Pain, Pain, Postoperative
Medical subject headings
Scoliosis, Kyphosis, Funnel Chest, Chronic Pain, Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric rating scale (NRS) pain scores

    Measured: Data will be collected for 48 hours postoperatively

  2. Occurrences of respiratory depression

    Respiratory rate (RR) <10 on POD 1 and 2

    Measured: Data will be collected for 48 hours postoperatively

  3. Occurrences of post-operative nausea/vomiting (PONV)

    Measured: Data will be collected for 48 hours postoperatively

Secondary outcomes (4)

  1. Amount of morphine (or equivalent) used by patient

    Measured: Data will be collected for 48 hours postoperative

  2. Chronic pain postoperatively

    Participants will complete questionnaires regarding pain since surgery was completed

    Measured: 2 - 6 months postoperatively

  3. Persistent pain postoperatively

    Participants will complete questionnaires regarding pain since surgery was completed

    Measured: 10 - 12 months postoperatively

  4. Opioid addiction by history on follow-up

    Measured: 1 year postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
880 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02998138
Sponsor's protocol ID
2015-8339
Other IDs
2015-8633
Status last verified
Oct 2026
First submitted
7 Mar 2016
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Einhorn LM, Monitto CL, Ganesh A, Duan Q, Lee J, Ramamurthi RJ, Barnett K, Ding L, Chidambaran V. Multi-Institutional Study of Multimodal Analgesia Practice, Pain Trajectories, and Recovery Trends After Spine Fusion for Idiopathic Scoliosis. Anesth Analg. 2025 Nov 1;141(5):1137-1148. doi: 10.1213/ANE.0000000000007351. Epub 2025 Jan 2.

    PubMed 39745877

  • Narayanasamy S, Yang F, Ding L, Geisler K, Glynn S, Ganesh A, Sathyamoorthy M, Garcia V, Sturm P, Chidambaran V. Pediatric Pain Screening Tool: A Simple 9-Item Questionnaire Predicts Functional and Chronic Postsurgical Pain Outcomes After Major Musculoskeletal Surgeries. J Pain. 2022 Jan;23(1):98-111. doi: 10.1016/j.jpain.2021.06.014. Epub 2021 Jul 17.

    PubMed 34280572

Questions about this trial

What is this clinical trial studying?

An observational study of Scoliosis and Kyphosis, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric rating scale (NRS) pain scores (time frame: Data will be collected for 48 hours postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02998138, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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