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

March 23, 2026 updated by: Erik de Loos, Zuyderland Medisch Centrum

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: The minimal invasive Nuss procedure is currently considered the treatment of choice for pectus excavatum. This procedure is usually associated with severe postoperative pain as great forces are employed on the thoracic cage to correct the sternal depression. Pain is the main limiting factor for early discharge. Epidural analgesia is currently considered gold standard for postoperative pain treatment. Alternative pain management strategies (e.g., patient-controlled analgesia and paravertebral nerve block) have also been described but fail in accomplishing adequate prolonged post-operative pain management. Alternatively, continuous use of opioids comes with side-effects like severe nausea, urinary retention and obstipation. Intercostal nerve cryoablation seems a promising novel technique for postoperative analgesia. Prior studies comparing intercostal cryoablation to other pain treatment modalities after pectus excavatum repair through the minimal invasive Nuss procedure report promising results, but pose significant limitations (e.g., small sample size, retrospective nature with non-matched patient groups or considerable confounders).

Objective: 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 treated with the minimal invasive Nuss procedure.

Study design: The study protocol is designed for a single center, prospective, unblinded, randomized clinical trial.

Study population & intervention: Intercostal nerve cryoablation will be compared to thoracic epidural analgesia in young pectus excavatum patients (i.e., 12-24 years of age) treated with the minimal invasive Nuss procedure. 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.

Main study parameters/endpoints: Postoperative length of hospital stay will be recorded as the primary endpoint. Secondary outcomes include: 1) pain intensity; 2) operative time; 3) opioid usage; 4) complications, including neuropathic pain; 5) creatine kinase activity; 6)intensive care unit admissions; 7) readmissions; 8) postoperative mobility; 9) health related quality of Life; 10) days to return to work/school; 11) number of postoperative outpatient visits and 12) hospital costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks for study participants are negligible as the cryoablation technique has already been effectively used in the Nuss procedure without any serious side effects. Also, participants will be monitored daily by nursing staff and surgeons while admitted to the hospital. Burden associated with participation in the current study consists of completion of several questionnaires preoperatively and postoperatively.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419 PC
        • Zuyderland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Intercostal nerve cryoablation
Intercostal nerve cryoablation is applied during Nuss procedure.
Other Names:
  • Cryoablation
Drug: 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.
Other Names:
  • Intercostal nerve block
Drug: Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)
Opioids
Other Names:
  • opioids, oxycodone (with prolonged discharge)
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.
Drug: Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)
Opioids
Other Names:
  • opioids, oxycodone (with prolonged discharge)
Drug: Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
Thoracic epidural is placed prior to Nuss procedure
Other Names:
  • Epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Hospitalization period, average of 5 days
Number of days of hospital admittance after the Nuss procedure.
Hospitalization period, average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Preoperative care unit before surgery, in the morning on postoperative day 1 and 2, and 7 days, 14 days, 3 months and 6 months post operation
Pain intensity at rest and during mobilization. Pain scores will be rated on the numeric rating scale (NRS, 1-10)
Preoperative care unit before surgery, in the morning on postoperative day 1 and 2, and 7 days, 14 days, 3 months and 6 months post operation
Operative time
Time Frame: During Nuss procedure
Operative time in minutes. Duration of cryoablation will be assessed separately. Operative time will not include the time needed for the placement of the thoracic epidural as placement will be performed in the preoperative care unit.
During Nuss procedure
Intensive care unit admission
Time Frame: Hospitalization period, average of 5 days
Intensive care unit admission due to the occurrence of perioperative complications in absolute numbers
Hospitalization period, average of 5 days
Length of intensive care unit admission
Time Frame: Hospitalization period, average of 5 days
Length of admission due to the occurrence of perioperative complications in absolute numbers.
Hospitalization period, average of 5 days
Number of readmissions
Time Frame: 6 months postoperative
Number of readmissions denoted as absolute numbers.
6 months postoperative
Length of readmissions
Time Frame: 6 months postoperative
length of readmissions denoted as absolute numbers.
6 months postoperative
Degree of mobility
Time Frame: Postoperative day 1 and 2
Degree of mobility measured on a 4-point scale (i.e., 1. on the bed, 2. to the chair, 3. to the toilet, 4. outside the patient's hospital room) during postoperative day 1 and 2.
Postoperative day 1 and 2
HRQOL - PEEQ
Time Frame: Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
HRQOL, measured by the Dutch version of the pectus evaluation questionnaire (PEEQ). The PEEQ is a validated disease specific questionnaire evaluating the quality of life in pectus excavatum patients (37,38).
Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
HRQOL - SF-36
Time Frame: Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
HRQOL, measured by the Dutch version of the short form health survey (SF-36)(37-40). The SF-36 is a generic questionnaire that taps health in eight dimensions (39).
Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
HRQOL - EQ-5D-5L
Time Frame: Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
HRQOL, measured by the Dutch version of the EuroQol 5 dimensions 5 levels (EQ-5D-5L) (37-40). For the EQ-5D-5L, participants will rate their health in 5 dimensions on 5 levels and will give an overall score of their health on a visual analogue scale (VAS) (40).
Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
Days to return to work/school
Time Frame: 6 months postoperative
Days to return to work/school, reported as days between discharge from hospital and return to work or school.
6 months postoperative
Postoperative visits
Time Frame: 6 months postoperative
Number of postoperative outpatient visits and telephone appointments denoted as absolute numbers in the first 6 months after the surgical procedure.
6 months postoperative
Hospital costs
Time Frame: 6 months postoperative
Hospital costs, reported as hospital costs during initial hospitalization (e.g., medication, patient care supply, surgical equipment), and hospital costs after discharge until 6 months follow-up (e.g., medications, outpatient visits, (opioid related) readmissions).
6 months postoperative
Opioid usage
Time Frame: postoperative day 1 and 2, and first 2 weeks after surgery
A) Intraoperative administered opioids; B) Opioid usage during postoperative day 0, 1 and 2 at the recovery unit and surgical ward; C) Opioid usage within the first 2 weeks after surgery. Opioid usage will be converted to oral morphine milligram equivalents (MME).
postoperative day 1 and 2, and first 2 weeks after surgery
Complications
Time Frame: 6 months postoperative
Complications graded according to the Clavien-Dindo classification. The most common procedure- and analgesia-related complications are defined in Supplementary Materials Table 1-2 for transparency, including neuropathic pain. Occurrence of neuropathic pain will be actively monitored during the hospitalization period, and during all follow-up appointments.
6 months postoperative
Creatine kinase (CK) activity
Time Frame: Preoperative and day 1 postoperative
CK levels will be assessed prior to the surgical procedure (i.e., baseline measurement during routine blood evaluation on the day of surgery) and on postoperative day 1. CK levels will be denoted in U/L.
Preoperative and day 1 postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Collaborators

AtriCure, Inc.

Investigators

  • Principal Investigator: Erik R De Loos, Zuyderland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2023

Primary Completion (Actual)

April 5, 2025

Study Completion (Actual)

October 22, 2025

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z2023005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Funnel Chest

Clinical Trials on Intercostal nerve cryoablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe