RECRUITING Not applicable ClinicalTrials.gov

ES Catheter vs Cryoablation After Pectus Surgery

Sponsor: Children's Hospital Medical Center, Cincinnati • ClinicalTrials.gov ID: NCT06682208

Registry updated: 2026-10-08

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Description

Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups: * Time to achieve short-term physical therapy goals and long-term functional outcomes * Compare immediate and long-term postoperative opioid use * Compare numbness on chest of postoperative day 1 and the return of sensation to baseline * Compare the incidence of neuropathic pain and other complications Participants will receive surveys for up to 12 months postoperatively.

Interventions

ES catheter (Procedure)
ES catheter for postoperative pain control
Intercostal nerve cryoablation (INC) (Procedure)
INC used for postoperative pain control

Eligibility criteria

Inclusion Criteria: * Age 12 - 21 years * History of pectus excavatum * Scheduled for Nuss procedure Exclusion Criteria: * Prior pectus repair * Other concomitant surgeries * Chronic pain conditions including Ehlers Danlos Syndrome * Non-English speaking - rationale: the questionnaires used in the study are in English language and the social and cultural factors of pain perception of non-English speaking patients could affect the study power * Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficulties communicating) * History of or active renal or liver disease * Major surgery requiring opioids in the last 2 years * Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month) * Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, uncontrolled hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included * BMI \>35 * Pregnant or breastfeeding females

Conditions

Pectus Excavatum

Locations

Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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