Postoperative and Chronic Pain Genetic Spine Surgery Study

Active, not recruiting

• Conditions: Scoliosis; Kyphosis; Kyphoscoliosis

• Registration Number: NCT02998138
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-3-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Children aged 10 to 18, inclusive, years of age<br><br> 2. Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis<br><br> 3. Scheduled for spine fusion.<br><br>Exclusion Criteria:<br><br> 1. Patients on chronic pain medication (opioid use over 6 months prior to surgery)<br><br> 2. Pregnant or breastfeeding females.<br><br> 3. Children with a history of or active renal or liver disease.<br><br> 4. Non-English speaking patients.<br><br> 5. Developmental delay<br><br> 6. Body Mass Index = 30<br><br> 7. Currently taking tricyclic, selective serotonin reuptake inhibitor (SSRI),<br> serotonin-norepinephrine reuptake inhibitor (SNRI) class of medications (within the<br> last month)<br><br> 8. Cardiac conditions including, but not limited to, cyanotic heart disease,<br> Hypoplastic Left Ventricle, arrhythmia, hypertension with ongoing treatment,<br> Kawasaki Disease, cardiomyopathies. Patients with asymptomatic valvular lesions or<br> defects may be included.<br><br> 9. Severe lung disease such as cystic fibrosis, pulmonary fibrosis, pneumonia within<br> the last month<br><br> 10. History of seizures currently treated on medication (patients off medication and<br> seizure free for greater than one year may be included)<br><br> 11. Other known genetic diseases including but not limited to Ehlers Danlos, Downs' etc.<br><br> 12. History of Obstructive sleep apnea by history (pauses during sleep, significant<br> snoring, use of CPAP)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS) pain scores;Occurrences of respiratory depression;Occurrences of post-operative nausea/vomiting (PONV)

Secondary Outcome Measures

Name	Time	Method
Amount of morphine (or equivalent) used by patient;Chronic pain postoperatively;Persistent pain postoperatively;Opioid addiction by history on follow-up