Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum (NCT05731973) | Clinical Trial Compass
CompletedNot Applicable
Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum
Netherlands50 participantsStarted 2023-12-08
Plain-language summary
Primary objective of the current study is to determine the impact of intercostal nerve cryoablation on postoperative length of hospital stay compared to standard pain management of young pectus excavatum patients (12-24 years) treated with the minimal invasive Nuss procedure. The study is designed as a single center, prospective, unblinded, randomized clinical trial.
Who can participate
Age range12 Years – 24 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Length of hospital stay
Timeframe: Hospitalization period, average of 5 days