Pectus excavatum
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Pectus excavatum patients, 12-24 years, who undergo the Nuss procedure
Exclusion criteria
Exclusion criteria: 1. A chest wall deformity other than pectus excavatum; 2. Opioid use in the 3 months prior to surgery; 3. Pain syndrome (e.g., fibromyalgia) or neuropathic pain prior to surgical repair of Pectus Excavatum; 4. Connective tissue disease (e.g., Marfan syndrome, Ehlers-Danlos syndrome); 5. Previous thoracic surgery or pectus excavatum repair; 6. Contraindication for INC or TEA (e.g., patient refusal, infection at the site of cannulation, uncontrolled systemic infection, bleeding diathesis, increased intracranial pressure, mechanical spine obstruction); 7. Psychiatric disease currently receiving treatment; 8. Not mastering the Dutch language; 9. Participation in another clinical trial that may interfere with the current trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative length of hospital stay will be recorded as the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include: 1) pain intensity 2) operative duration; 3) opioid usage; 4) cryoanalgesia- or epidural-related complications including neuropathic pain; 5) creatine kinase activity; 6) intensive care unit admissions; 7) readmissions; 8) mobility; 9) health related quality of Life; 10) days to return to work/school; 11) number of postoperative outpatient visits and 12) hospital costs. | — |
Countries
Netherlands