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NCT Number: NCT06682208

ES Catheter vs Cryoablation 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.

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Key information

Conditions

Pectus Excavatum Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ES catheter

Procedure

ES catheter for postoperative pain control

Intercostal nerve cryoablation (INC)

Procedure

INC used for postoperative pain control

Primary outcomes

  1. Compare time to reach discharge

    Time frame: Day of surgery up tp 10 days post-operative

    Comparing physical therapy goals to meet discharge criteria.

Secondary outcomes

  1. Opioid consumption

    Time frame: Day of surgery to up to one year

    Comparing opioid consumption

  2. Numbness on chest

    Time frame: Day of surgery and post-operative day 1

    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

  3. Neuropathic pain

    Time frame: Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively

    Surveys will be used to compare the incidence of neuropathic pain

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 12, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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