Clinical trial Recruiting at 1 site Interventional Ages 12 to 21

Comparing pain management methods after pectus surgery

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

Run by Children's Hospital Medical Center, Cincinnati · NCT06682208 · Data updated 2026-11-12

This study is testing whether using an ES catheter or cryoablation helps people recovering from pectus surgery manage their pain better and reach their physical therapy goals.

Quick facts

Study typeInterventional
Ages12 Years to 21 Years
SexAll
Enrollment176 (estimated)
SponsorChildren's Hospital Medical Center, Cincinnati
Academic / other
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedApril 8, 2024
Main results expectedApril 2029
Study endsApril 2029
Registry record updatedOctober 8, 2026
Trial IDNCT06682208 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adolescents and young adults aged 12 to 21 who have a history of pectus excavatum and are scheduled for the Nuss procedure.

Probably not a fit

Patients with prior pectus repair, chronic pain conditions, or severe developmental delays may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves participants who are scheduled to undergo the Nuss procedure for pectus excavatum. They will be randomly assigned to receive either an ES catheter or cryoablation for postoperative pain management. The study aims to evaluate various outcomes, including the time to achieve physical therapy goals, opioid usage, sensation recovery, and the incidence of neuropathic pain over a 12-month period. Participants will complete surveys to assess their recovery and pain levels.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients recovering from pectus surgery.

How similar studies have gone: Other studies have explored pain management techniques in surgical settings, but this specific comparison of ES catheter and cryoablation is novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States
    Recruiting

Study contacts

  • Principal investigator: Charlotte Walter, MD — Children's Hospital Medical Center, Cincinnati
  • Study coordinator: Charlotte Walter, MD
  • Email: Charlotte.Walter@cchmc.org
  • Phone: 513-636-4408

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.