ES Catheter vs Cryoablation After Pectus Surgery

Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pectus Excavatum
• Intervention / Treatment: Procedure: ES catheter; Procedure: Intercostal nerve cryoablation (INC)

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristie Geisler, BS; Phone Number: 513-636-3282; Email: kristie.geisler@cchmc.org
• Study Contact Backup: Name: Charlotte Walter, MD; Phone Number: 513-636-4408; Email: charlotte.walter@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Kristie Geisler, BS; Phone Number: 513-636-3282; Email: kristie.geisler@cchmc.org
      • Contact: Charlotte Walter, MD; Phone Number: 513-636-4408; Email: charlotte.walter@cchmc.org
      • Principal Investigator: Charlotte Walter, MD
      • Principal Investigator: Surya Narayanasamy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ES Catheter; Hospital procedure for ES catheters will be followed for postoperative pain.	Procedure: ES catheter; ES catheter for postoperative pain control
Active Comparator: Intercostal Nerve Cryoablation (INC); Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.	Procedure: Intercostal nerve cryoablation (INC); INC used for postoperative pain control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare time to reach discharge	Comparing physical therapy goals to meet discharge criteria.	Day of surgery up tp 10 days post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Comparing opioid consumption	Day of surgery to up to one year
Numbness on chest	An exam glove with ice will used on the anterior axillary line to obtain a rating of the sensation felt. 0 - no sensation; - lessened sensation; - abnormal/painful sensation; - no sensation	Day of surgery and post-operative day 1
Neuropathic pain	Surveys will be used to compare the incidence of neuropathic pain	Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Charlotte Walter, MD, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Surya Narayanasamy, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Funnel Chest
• Other Study ID Numbers: 2022-0760

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No