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

NCT05731973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Pectus Excavatum
  • Funnel Chest

Interventions

PROCEDURE

Intercostal nerve cryoablation

Intercostal nerve cryoablation is applied during Nuss procedure.

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

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.

DRUG

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

Opioids

Sponsors & Collaborators

  • AtriCure, Inc.

    collaborator INDUSTRY

  • Zuyderland Medisch Centrum

    lead OTHER

Principal Investigators

  • Erik R De Loos · Zuyderland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2025-04-05
Completion
2025-10-22

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05731973 on ClinicalTrials.gov