Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum (ICE)
Pectus Excavatum, Funnel Chest
About this trial
This is an interventional other trial for Pectus Excavatum focused on measuring Pectus Excavatum, Funnel Chest, Intercostal nerve cryoablation, Analgesia
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.
Sites / Locations
- Zuyderland Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intercostal nerve cryoablation
Thoracic epidural (local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
When a patient is allocated to the intercostal nerve cryoablation group, cryoablation will be performed prior to bar placement. In brief, cryoablation will be performed at the level of the bar and two levels above and below, bilaterally. For this, a second portal access will be placed for video guidance on the contralateral side, and the cryoprobe (cryoICE, Atricure, Masion, OH, USA) will be inserted through the thoracic incisions that are already made for bar placement. The probe will be placed at the inferior aspect of the ribs, posterior to the midaxillary line, directly on the neurovascular bundle. One freezing cycle takes 2 minutes, and a temperature of -60 ⁰C will be applied. The probe will be warmed to room temperature before removing it from the pleura to prevent additional trauma. Furthermore, intercostal nerve cryoablation will be combined with single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks placed just anterior to the side of the cryoablation.
Prior to surgery, an anesthesiologist will place the thoracic epidural at T5-T6 or T6-T7 interspace in the awake patient. After correct placement, a local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml) will be started. At the third postoperative day, thoracic epidural analgesia will be ceased and transitioned to oral pain medication at discretion of the pain management team. In general, opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours as needed) will be provided 12 hours before thoracic epidural analgesia is ceased.