RECRUITING

ES Catheter Vs Cryoablation After Pectus Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-08
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06682208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 12 - 21 years
  2. * History of pectus excavatum
  3. * Scheduled for Nuss procedure
  1. * Prior pectus repair
  2. * Other concomitant surgeries
  3. * Chronic pain conditions including Ehlers Danlos Syndrome
  4. * 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
  5. * Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficulties communicating)
  6. * History of or active renal or liver disease
  7. * Major surgery requiring opioids in the last 2 years
  8. * Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
  9. * 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
  10. * BMI \>35
  11. * Pregnant or breastfeeding females

Contacts and Locations

Study Contact

Charlotte Walter, MD
CONTACT
513-636-4408
Charlotte.Walter@cchmc.org
Kristie Geisler, BS
CONTACT
513-636-3282
Kristie.geisler@cchmc.org

Principal Investigator

Charlotte Walter, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Surya Narayanasamy, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Charlotte Walter, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati
  • Surya Narayanasamy, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-08
Study Completion Date2029-04

Study Record Updates

Study Start Date2024-04-08
Study Completion Date2029-04

Terms related to this study

Additional Relevant MeSH Terms

  • Pectus Excavatum