CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml)) +3 moredrug
Likely dose
Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))from record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05731973
NCT05731973N/ACompleted
CompareCT.gov

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

Zuyderland Medisch Centrum·interventional·Posted Feb 16, 2023·Updated Mar 25, 2026

In Brief

A clinical study evaluating Intercostal nerve cryoablation, Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml)), and 2 other interventions for Pectus Excavatum and Funnel Chest. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPectus Excavatum, Funnel Chest
CountriesNetherlands
CollaboratorsAtriCure, Inc.

Timeline

N/ACompletedFinished
202420252026
First PostedFeb 16, 2023
Enrollment StartDec 8, 2023
Primary CompletionApr 5, 2025
Study CompletionOct 22, 2025
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.4 years ago

Interventions

Intercostal nerve cryoablationprocedure

Intercostal nerve cryoablation is applied during Nuss procedure.

Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))drug

Thoracic epidural is placed prior to Nuss procedure

Intercostal nerve block (single shot bupivacaine (1.25 mg/ml))drug

Single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks are placed just anterior to the side of the cryoablation.

Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)drug

Opioids