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Intercostal nerve cryoablation versus thoracic epidural analgesia for minimal invasive Nuss repair of pectus excavatum: A protocol for a randomized clinical trial (ICE trial)

Intercostal nerve cryoablation versus thoracic epidural analgesia for minimal invasive Nuss repair of pectus excavatum: A protocol for a randomized clinical trial (ICE trial) - ICE: Intercostal nerve Cryoablation versus Epidural analgesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53766
Enrollment
50
Registered
2023-04-04
Start date
2023-12-08
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pectus excavatum

Interventions

Intercostal nerve cryoablation complemented with intercostal nerve blocks.

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 64 Years

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

MeasureTime frame
Postoperative length of hospital stay will be recorded as the primary endpoint.

Secondary

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026