RecruitingNot ApplicableNCT06682208

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

176 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Pectus excavatum

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

Min Age: 12 YearsMax Age: 21 Years

Inclusion Criteria3

Age 12 - 21 years
History of pectus excavatum
Scheduled for Nuss procedure

Exclusion Criteria11

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