Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum

Launched by ZUYDERLAND MEDISCH CENTRUM · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two ways to manage pain after a specific surgery called the Nuss procedure, which is used to correct a chest condition known as pectus excavatum (often called funnel chest). The study is comparing a method called intercostal nerve cryoablation (which involves freezing certain nerves to reduce pain) with the standard pain management method known as epidural analgesia. Researchers want to see if using cryoablation can help patients go home from the hospital sooner after their surgery.

To be eligible for this trial, participants must be between the ages of 12 and 24 and scheduled for the Nuss procedure to fix their pectus excavatum. Certain conditions, like previous chest surgery or specific health issues, may exclude someone from participating. If you join this trial, you'll be randomly assigned to receive either the nerve freezing treatment or the standard pain management, and the team will closely monitor your recovery and experiences regarding pain and hospital stay. This research aims to improve pain management options for young patients undergoing this surgery.

Gender

ALL

Eligibility 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.