Cryoanalgesia vs. Epidural in the Nuss Procedure

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Harrison; University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Food and Drug Administration (FDA)
• Treatments: Fentanyl

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