Transverse Thoracic Plane Block in the Pediatric Cardiac... | NCT04138745

Studies
Transverse Thoracic Plane Block in the Pediatric Cardiac Patient

NCT04138745

Sponsor

Ochsner Health System

Status

Completed

Last Update Posted

Sep 9, 2021Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Pain, Acute
Congenital Heart Disease

Interventions

Transverse Thoracic Plane Block

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Oct 23, 2019

First Submission Date that Met QC Criteria

Oct 23, 2019

First Posted Date

Oct 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2021

Last Update Posted Date

Sep 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Postoperative pain after cardiothoracic surgery can be a significant problem interfering with recovery, yet difficult to manage due to the sedating effects of opiates. These patients frequently have associated postoperative pulmonary changes and are at risk of respiratory depression with opioid analgesia. The ultrasound-guided transversus thoracic muscle plane block (TTMPB) is a recently described regional anesthetic technique showing improvements in postoperative pain management. Further investigation is needed to establish the potential of the TTMPB as an analgesic modality in congenital cardiothoracic surgery in patients under the age of 18.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Historical control patients that are matched to the surgery type
Experimental		After the practice change of TTP was initiated, the future pediatric patients were put into a database.	Other: Transverse Thoracic Plane Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transverse Thoracic Plane Block	Other	A bilateral plane block in the transverse thoracic space	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Extubation	The amount of time until the patients are extubated in the ICU or OR.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Surgical Stress Response	HR response to incision	2 years
Opiate Usage	Amount of total opiates used for the heart surgery	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Congenital Heart Surgery

Exclusion Criteria:

Over 18

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All comers int he age groups above

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
DOMINIC S CAROLLO, MD	Ochsner Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner Health System		New Orleans	Louisiana	70121	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided