Phase 4 N=20 Randomized Treatment

Cryoanalgesia vs. Epidural in the Nuss Procedure

Pectus Excavatum · Funnel Chest

Bottom Line

View on ClinicalTrials.gov: NCT02721017 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

May 2021

Primary outcome: Primary: Length of Hospitalization — 3; 5 Length of Stay (Post-Operative Days)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cryoanalgesia (Device); Thoracic epidural (ropivicaine, fentanyl) (Drug)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Length of Hospitalization	3; 5	—
SECONDARY Narcotic Usage	268; 684	—
SECONDARY Mean Neuropathic Pain Score at One Year	2.4; 1.9	—
SECONDARY Cost Analysis	—	—

Summary

The purpose of this study is to determine whether cryoanalgesia provides better pain control for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.

Eligibility Criteria

Inclusion Criteria

scheduled for Nuss procedure for pectus excavatum correction
at least 13 years old at the time of the procedure

Exclusion Criteria

age less than 13 years at time of procedure
use of pain medication prior to procedure
pectus carinatum, Poland's syndrome, or any chest wall anomaly other than pectus excavatum
previous repair of pectus excavatum by any technique
previous thoracic surgery
congenital heart disease
bleeding dyscrasia
major anesthetic risk factors or history of previous problem with anesthesia
pregnancy
inability to communicate in English

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02721017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.