Clinical trial NCT06682208: ES Catheter vs Cryoablation After Pectus Surgery
Official title: Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pectus Excavatum
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 176
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Compare time to reach discharge
timeFrame: Day of surgery up tp 10 days post-operative
Secondary outcomes:
measure: Opioid consumption
timeFrame: Day of surgery to up to one year
measure: Numbness on chest
timeFrame: Day of surgery and post-operative day 1
measure: Neuropathic pain
timeFrame: Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Charlotte Walter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Surya Narayanasamy, MD
role: PRINCIPAL_INVESTIGATOR
References: