Comparing intercostal nerve cryoablation and epidural analgesia for pain management in pectus excavatum surgery
Intercostal Nerve Cryoablation Versus Thoracic Epidural Analgesia for Minimal Invasive Nuss Repair of Pectus Excavatum: a Randomized Clinical Trial (ICE Trial)
This study is testing if a new pain management technique using cryoablation works better than the standard epidural for young patients recovering from surgery for pectus excavatum.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 12 Years to 24 Years |
| Sex | All |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Locations | 1 site (Heerlen, Limburg) |
| Trial ID | NCT05731973 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intercostal nerve cryoablation compared to standard epidural analgesia in managing postoperative pain for young patients undergoing the Nuss procedure for pectus excavatum. The study is a single-center, prospective, unblinded, randomized trial that focuses on reducing the length of hospital stay by improving pain management. By addressing the limitations of current pain management strategies, the trial seeks to provide a more effective alternative for postoperative care in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are young patients aged 12-24 years who are scheduled for the Nuss procedure to correct pectus excavatum.
Not a fit: Patients with other chest wall deformities, prior opioid use, or specific medical conditions that contraindicate the interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and shorten hospital stays for young patients undergoing surgery for pectus excavatum.
How similar studies have performed: Previous studies have shown promising results for intercostal nerve cryoablation in similar contexts, although they faced limitations such as small sample sizes and retrospective designs.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing the minimal invasive Nuss procedure for surgical repair of pectus excavatum. * Young patients (12-24 years of age) according to the definition used by the World Health Organization. This cut-off point is chosen to create a more homogenous patient sample, as the thoracic cage is fully matured by the age of 24, in size and density, which will have an effect on postoperative pain. Exclusion Criteria: * A chest wall deformity other than pectus excavatum; * Opioid use in the 3 months prior to surgery; * Pain syndrome (e.g., fibromyalgia) or neuropathic pain prior to surgical repair of pectus excavatum; * Connective tissue disease (e.g., Marfan syndrome, Ehlers-Danlos syndrome); * Previous thoracic surgery or pectus excavatum repair; * Contraindication for intercostal nerve cryoablation or thoracic epidural analgesia (e.g., patient refusal, infection at the site of cannulation, uncontrolled systemic infection, bleeding diathesis, increased intracranial pressure, mechanical spine obstruction); * Psychiatric disease currently receiving treatment; * Not mastering the Dutch language; * Participation in another clinical trial that may interfere with the current trial.
Where this trial is running
Heerlen, Limburg
- Zuyderland Medical Center — Heerlen, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erik R De Loos — Zuyderland Medical Center
- Study coordinator: Erik R De Loos
- Email: e.deloos@zuyderland.nl
- Phone: 088-4597777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.