Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 21
Healthy Volunteers: f
View:
• Age 12 - 21 years
• History of pectus excavatum
• Scheduled for Nuss procedure
Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Charlotte Walter, MD
Charlotte.Walter@cchmc.org
513-636-4408
Backup
Kristie Geisler, BS
Kristie.geisler@cchmc.org
513-636-3282
Time Frame
Start Date: 2024-04-08
Estimated Completion Date: 2029-04
Participants
Target number of participants: 176
Treatments
Active_comparator: ES Catheter
Hospital procedure for ES catheters will be followed for postoperative pain.
Active_comparator: Intercostal Nerve Cryoablation (INC)
Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati