🏛️ Verified NIH Record • Updated 2025-06-11

Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery (NCT04031716)

Genetic, Epigenetic, Psychosocial, and Biological Determinants of Post-surgical Pain After Pectus or Spine Surgery

🔵 Active, Not Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Children's Hospital Medical Center, Cincinnati

🩺 Plain-English Summary (8th-Grade Level)

This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (12 items).

Location: Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio

Age range: 8 Years

🧪 Interventions in This Study

  • Meditation (BEHAVIORAL)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • History of or active renal or liver disease
  • Major surgery requiring opioids in the last 5 years
  • Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
  • Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included
  • History of seizures currently treated on medication (participants off medication and seizure free for greater than one year may be included)
  • Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine
  • Needing postoperative ventilation or intraoperative cardiac bypass standby
  • BMI \>35
  • Pregnant or breastfeeding females
  • Non-English speaking
  • Definite developmental delay

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗