Clinical trial
Intercostal Nerve Cryoablation Versus Thoracic Epidural Analgesia for Minimal Invasive Nuss Repair of Pectus Excavatum: a Randomized Clinical Trial (ICE Trial)
Name
Z2023005
Description
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.
Trial arms
Trial start
2023-12-08
Estimated PCD
2025-01-01
Trial end
2025-09-01
Status
Recruiting
Treatment
Intercostal nerve cryoablation
Intercostal nerve cryoablation is applied during Nuss procedure.
Arms:
Intercostal nerve cryoablation
Other names:
Cryoablation
Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
Thoracic epidural is placed prior to Nuss procedure
Arms:
Thoracic epidural (local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
Other names:
Epidural
Intercostal nerve block (single shot bupivacaine (1.25 mg/ml))
Single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks are placed just anterior to the side of the cryoablation.
Arms:
Intercostal nerve cryoablation
Other names:
Intercostal nerve block
Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)
Opioids
Arms:
Intercostal nerve cryoablation, Thoracic epidural (local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
Other names:
opioids, oxycodone (with prolonged discharge)
Size
50
Primary endpoint
Length of hospital stay
Hospitalization period, average of 5 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single center, prospective, unblinded, randomized clinical trial. Block randomization, including stratification based on age (12-16 years and 17-24 years) and sex, with an allocation ratio of 1:1 will be performed.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-01-05
1 organization
3 products
1 indication
Organization
Zuyderland Medisch CentrumProduct
Thoracic epidural analgesiaIndication
Pectus ExcavatumProduct
Intercostal nerve blockProduct
Opioids (oxycodone)