ES Catheter vs Cryoablation After Pectus Surgery

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06682208
Status
Recruiting
Apply to this trial

Conditions

  • Pectus Excavatum

Eligibility Criteria

Sex
ALL
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • ES catheter — PROCEDURE
    ES catheter for postoperative pain control
  • Intercostal nerve cryoablation (INC) — PROCEDURE
    INC used for postoperative pain control

Study Details

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.

Key Dates

Start date
Apr 8, 2024
Status verified
Sep 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Compare time to reach discharge [ Time Frame: Day of surgery up tp 10 days post-operative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Charlotte Walter, MD
[email protected]
513-636-4408
Kristie Geisler, BS
[email protected]
513-636-3282
Charlotte Walter, MD (PRINCIPAL_INVESTIGATOR)
Surya Narayanasamy, MD (PRINCIPAL_INVESTIGATOR)

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Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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