Comparing pain management methods after pectus surgery
Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery
NA · Children's Hospital Medical Center, Cincinnati · NCT06682208
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06682208 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with prior pectus repair, chronic pain conditions, or severe developmental delays may not benefit from this study.
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 performed: Other studies have explored pain management techniques in surgical settings, but this specific comparison of ES catheter and cryoablation is novel.
Eligibility criteria
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 this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pectus Excavatum