ES Catheter vs Cryoablation After Pectus Surgery

Not Applicable

Recruiting

• Conditions: Pectus Excavatum

• Registration Number: NCT06682208
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-08
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare time to reach discharge	Day of surgery up tp 10 days post-operative	Comparing physical therapy goals to meet discharge criteria.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	Day of surgery to up to one year	Comparing opioid consumption
Numbness on chest	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; 1. - lessened sensation; 2. - abnormal/painful sensation; 3. - no sensation
Neuropathic pain	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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States