ES Catheter vs Cryoablation After Pectus Surgery
ConditionPectus Excavatum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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
Qualifiers
Age 12 - 21 years
History of pectus excavatum
Scheduled for Nuss procedure
Disqualifiers
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
Trial design
Treatments tested in this trial
- ES catheter
- Intercostal nerve cryoablation (INC)
Treatment groups
176 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov