NCT02721017

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 5, 2021

Completed
Last Updated

May 5, 2021

Status Verified

May 1, 2021

Enrollment Period

2.3 years

First QC Date

March 22, 2016

Results QC Date

August 27, 2019

Last Update Submit

May 3, 2021

Conditions

Pectus ExcavatumFunnel Chest

Keywords

NussNuss Procedurepectus excavatumcryoanalgesia

Outcome Measures

Primary Outcomes (1)

  • Length of Hospitalization

    the length of the patient's in-hospital stay following admission for Nuss procedure

    estimated one week or less

Secondary Outcomes (3)

  • Narcotic Usage

    Post Operative Hospital Stay

  • Mean Neuropathic Pain Score at One Year

    one year

  • Cost Analysis

    estimated one week

Study Arms (2)

Cryoanalgesia

EXPERIMENTAL

Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure

Device: Cryoanalgesia

Thoracic Epidural

ACTIVE COMPARATOR

Thoracic epidural (ropivicaine, fentanyl).

Drug: Thoracic epidural (ropivicaine, fentanyl)

Interventions

CryoanalgesiaDEVICE
Also known as: AtriCure, cryoprobe, nerve freezing
Cryoanalgesia
Thoracic epidural (ropivicaine, fentanyl)DRUG

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

Also known as: Epidural
Thoracic Epidural

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF-Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Related Publications (2)

  • Graves C, Idowu O, Lee S, Padilla B, Kim S. Intraoperative cryoanalgesia for managing pain after the Nuss procedure. J Pediatr Surg. 2017 Jun;52(6):920-924. doi: 10.1016/j.jpedsurg.2017.03.006. Epub 2017 Mar 16.

    PMID: 28341230BACKGROUND

  • Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.

    PMID: 30935731RESULT

MeSH Terms

Conditions

Funnel Chest

Interventions

TeaFentanylInjections, Epidural

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsInjections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Dr. Benjamin Padilla
Organization
University of California San Francisco Department of Surgery
Benjamin.Padilla@ucsf.edu
415-476-3642

Study Officials

  • Benjamin Padilla, MD

    415-370-2835

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

March 28, 2016

Study Start

May 1, 2016

Primary Completion

August 28, 2018

Study Completion

September 1, 2018

Last Updated

May 5, 2021

Results First Posted

May 5, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)