ES Catheter vs Cryoablation After Pectus Surgery

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Pectus Excavatum

Treatments: Procedure: Intercostal nerve cryoablation (INC); Procedure: ES catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06682208

2022-0760

Details and patient eligibility

About

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

ES Catheter

Active Comparator group

Description:

Hospital procedure for ES catheters will be followed for postoperative pain.

Treatment:

Procedure: ES catheter

Intercostal Nerve Cryoablation (INC)

Active Comparator group

Description:

Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.

Treatment:

Procedure: Intercostal nerve cryoablation (INC)