Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
176 participants
INTERVENTIONAL
2024-04-08
2029-04-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ES Catheter
Hospital procedure for ES catheters will be followed for postoperative pain.
ES catheter
ES catheter for postoperative pain control
Intercostal Nerve Cryoablation (INC)
Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.
Intercostal nerve cryoablation (INC)
INC used for postoperative pain control
Interventions
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ES catheter
ES catheter for postoperative pain control
Intercostal nerve cryoablation (INC)
INC used for postoperative pain control
Eligibility Criteria
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Inclusion Criteria
* History of pectus excavatum
* Scheduled for Nuss procedure
Exclusion Criteria
* 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
12 Years
21 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Charlotte Walter, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Surya Narayanasamy, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-0760
Identifier Type: -
Identifier Source: org_study_id
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