NCT04138745

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

October 23, 2019

Last Update Submit

September 8, 2021

Conditions

Pain, AcuteCongenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Extubation

    The amount of time until the patients are extubated in the ICU or OR.

    2 years

Secondary Outcomes (2)

  • Surgical Stress Response

    2 years

  • Opiate Usage

    2 years

Study Arms (2)

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

Transverse Thoracic Plane BlockOTHER

A bilateral plane block in the transverse thoracic space

Experimental

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All comers int he age groups above

You may qualify if:

  • Congenital Heart Surgery

You may not qualify if:

  • Over 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Acute PainHeart Defects, Congenital

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • DOMINIC S CAROLLO, MD

    Ochsner Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Physician

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 24, 2019

Study Start

January 1, 2018

Primary Completion

November 1, 2019

Study Completion

December 31, 2020

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

US(1)