ES Catheter vs Cryoablation After Pectus Surgery

NCT06682208 — Not applicable, Recruiting, 176 participants, Children's Hospital Medical Center, Cincinnati

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Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery

Registry	NCT06682208
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	176 (Estimated)
Sponsor	Children's Hospital Medical Center, Cincinnati (Other)
Conditions	Pectus Excavatum
Interventions	ES catheter, Intercostal nerve cryoablation (INC) (Procedure)
Dates	start 2024-04-08, primary completion 2029-04-01 (estimated), completion 2029-04-01 (estimated), first posted 2024-11-12, last updated 2026-10-08
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
ES Catheter	Active comparator	Procedure: ES catheter	Hospital procedure for ES catheters will be followed for postoperative pain.
Intercostal Nerve Cryoablation (INC)	Active comparator	Procedure: Intercostal nerve cryoablation (INC)	Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.

ES catheter (Procedure): ES catheter for postoperative pain control
Intercostal nerve cryoablation (INC) (Procedure): INC used for postoperative pain control

+Outcome measures

Primary outcomes

Compare time to reach discharge [Day of surgery up tp 10 days post-operative]: Comparing physical therapy goals to meet discharge criteria.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 12 Years to 21 Years

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

+Locations (1)

Facility	City	Country	Status
Cincinnati Children's Hospital Medical Center	Cincinnati, Ohio	United States	Recruiting

+Investigators

Charlotte Walter, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
Surya Narayanasamy, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati