Pectus Excavatum
Conditions
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.
Interventions
PROCEDUREES catheter
ES catheter for postoperative pain control
PROCEDUREIntercostal nerve cryoablation (INC)
INC used for postoperative pain control
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare time to reach discharge | Day of surgery up tp 10 days post-operative | Comparing physical therapy goals to meet discharge criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactCharlotte Walter, MD
Backup ContactKristie Geisler, BS
Outcome results
None listed