Recruiting

ES Catheter vs. Cryoablation

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06682208

Conditions

Pectus Excavatum

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Interventions

ES catheter

Intercostal nerve cryoablation (INC)

Study Details

Brief summary:

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.

Conditions

Pectus Excavatum

Study ID

NCT06682208

Start date

Apr 8, 2024

Status verified date

Sep, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: ES Catheter

Hospital procedure for ES catheters will be followed for postoperative pain.

active comparator: Intercostal Nerve Cryoablation (INC)

Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.

Interventions

ES catheter

ES catheter for postoperative pain control

Intercostal nerve cryoablation (INC)

INC used for postoperative pain control

Primary outcome measure

  • Compare time to reach discharge [ Time Frame: Day of surgery up tp 10 days post-operative ]

Central Contacts and Locations

Central contacts

Charlotte Walter, MD

513-636-4408Charlotte.Walter@cchmc.org

Kristie Geisler, BS

513-636-3282Kristie.geisler@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Charlotte Walter, MD

513-636-4408charlotte.walter@cchmc.org

Kristie Geisler, BS

513-636-3282kristie.geisler@cchmc.org

Principal Investigator:

Charlotte Walter, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-09-18.