ES Catheter vs Cryoablation After Pectus Surgery

Last updated: December 20, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ES catheter

Intercostal nerve cryoablation (INC)

Clinical Study ID

NCT06682208
2022-0760
  • Ages 12-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 12 - 21 years

  • History of pectus excavatum

  • Scheduled for Nuss procedure

Exclusion

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 inEnglish language and the social and cultural factors of pain perception ofnon-English speaking patients could affect the study power

  • Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficultiescommunicating)

  • 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 ongoingtreatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomaticvalvular lesions or defects may be included

  • BMI >35

  • Pregnant or breastfeeding females

Study Design

Total Participants: 176
Treatment Group(s): 2
Primary Treatment: ES catheter
Phase:
Study Start date:
April 08, 2024
Estimated Completion Date:
April 30, 2029

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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