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

Conditions: Pectus excavatum
Funnel chest
10013369

Registration Number: NL-OMON53766

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Pectus excavatum patients, 12-24 years, who undergo the Nuss procedure

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative length of hospital stay will be recorded as the primary endpoint. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include: 1) pain intensity 2) operative duration; 3) opioid<br /><br>usage; 4) cryoanalgesia- or epidural-related complications including<br /><br>neuropathic pain; 5) creatine kinase activity; 6) intensive care unit<br /><br>admissions; 7) readmissions; 8) mobility; 9) health related quality of Life;<br /><br>10) days to return to work/school; 11) number of postoperative outpatient<br /><br>visits and 12) hospital costs. </p><br>