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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zuyderland Medisch Centrum
• Collaborator: AtriCure, Inc.
• Treatments: Analgesics, Opioid; Bupivacaine; Oxycodone; Sufentanil

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.