Transverse Thoracic Plane Block in the Pediatric Cardiac Patient (TTPPCT)

September 8, 2021 updated by: Dominic Carollo, Ochsner Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All comers int he age groups above

Description

Inclusion Criteria:

  • Congenital Heart Surgery

Exclusion Criteria:

  • Over 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
A bilateral plane block in the transverse thoracic space

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Principal Investigator: DOMINIC S CAROLLO, MD, Ochsner Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (ACTUAL)

October 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTP Peds Cardiac

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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