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Cryoanalgesia vs. Epidural in the Nuss Procedure

NCT02721017 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-05-05

Study results available
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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.

Conditions

  • Pectus Excavatum
  • Funnel Chest

Interventions

DEVICE

Cryoanalgesia

DRUG

Thoracic epidural (ropivicaine, fentanyl)

Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Benjamin Padilla, MD · 415-370-2835

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-08-28
Completion
2018-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02721017 on ClinicalTrials.gov