Postoperative and Chronic Pain Genetic Spine Surgery Study

NCT02998138 | Active Not Recruiting

• 2 other identifiers: 2015-83392015-8633
• Study Type: observational
• Target: 880
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Scoliosis; Kyphosis; Kyphoscoliosis

Keywords

Chronic Pain; Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• Numeric rating scale (NRS) pain scores

  Data will be collected for 48 hours postoperatively

• Occurrences of respiratory depression

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

  Data will be collected for 48 hours postoperatively

• Occurrences of post-operative nausea/vomiting (PONV)

  Data will be collected for 48 hours postoperatively

Secondary Outcomes (4)

• Amount of morphine (or equivalent) used by patient

  Data will be collected for 48 hours postoperative

• Chronic pain postoperatively

  2 - 6 months postoperatively

• Persistent pain postoperatively

  10 - 12 months postoperatively

• Opioid addiction by history on follow-up

  1 year postoperatively

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit a total of 200 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 to 18, inclusive, years scheduled for spinal surgical procedures.

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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (5)

Stanford University Hospital

Stanford, California, 94305, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Duke Children's Hospital

Durham, North Carolina, 27710, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 34280572 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be analyzed for a defined set of SNPs using PCR (TaqMan, ABI)/and Omni5M GWAS chip testing. DNA will be isolated from blood samples and also be used for pyrosequencing studies to obtain DNA methylation information for a specified set of genes or use of the MethylationEPIC array. The SNP sets were chosen using the adult studies cited in the Background and Significance section as evidence of potential importance. Given that the pain response in children and adolescents may involve a novel or different set of SNPs and additional SNPs of the above genes, the DNA samples gathered will be held for future analysis.

MeSH Terms

Conditions

Scoliosis; Kyphosis; Chronic Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Vidya Chidambaran, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)