Active — Not RecruitingNot Applicable

Postoperative and Chronic Pain Genetic Spine Surgery Study

United States880 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range10 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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.

What they're measuring

Numeric rating scale (NRS) pain scores

Timeframe: Data will be collected for 48 hours postoperatively

Occurrences of respiratory depression

Timeframe: Data will be collected for 48 hours postoperatively

Occurrences of post-operative nausea/vomiting (PONV)

Timeframe: Data will be collected for 48 hours postoperatively

Trial details

NCT IDNCT02998138

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Scoliosis trials

Plain-language summary

Who can participate

Age range10 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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.

What they're measuring

Numeric rating scale (NRS) pain scores

Timeframe: Data will be collected for 48 hours postoperatively

Occurrences of respiratory depression

Timeframe: Data will be collected for 48 hours postoperatively

Occurrences of post-operative nausea/vomiting (PONV)

Timeframe: Data will be collected for 48 hours postoperatively