Intercostal Nerve Cryoablation Versus Thoracic Epidural Analgesia for Minimal Invasive Nuss Repair of Pectus Excavatum: a Randomized Clinical Trial (ICE Trial)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 24
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Zuyderland Medical Center
RECRUITING
Heerlen
Contact Information
Primary
Erik R De Loos
e.deloos@zuyderland.nl
088-4597777
Backup
Aimée Franssen
ai.franssen@zuyderland.nl
088-4597777
Time Frame
Start Date: 2023-12-08
Estimated Completion Date: 2025-09
Participants
Target number of participants: 50
Treatments
Experimental: Intercostal nerve cryoablation
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.
Active_comparator: Thoracic epidural (local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
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.
Related Therapeutic Areas
Sponsors
Collaborators: AtriCure, Inc.
Leads: Zuyderland Medisch Centrum

This content was sourced from clinicaltrials.gov