ES Catheter vs Cryoablation After Pectus Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ES catheter, Intercostal nerve cryoablation (INC).
- Who it may be relevant to
- Registry conditions: Pectus Excavatum. Basic parameters: 12 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery
Overview
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
- Procedure ES catheter
ES catheter for postoperative pain control - Procedure Intercostal nerve cryoablation (INC)
INC used for postoperative pain control
Primary outcome measures
- Compare time to reach discharge [Time frame: Day of surgery up tp 10 days post-operative]
Secondary outcome measures (3)
- Opioid consumption [Time frame: Day of surgery to up to one year]
- Numbness on chest [Time frame: Day of surgery and post-operative day 1]
- Neuropathic pain [Time frame: Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT06682208 · 2022-0760