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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04138745
Other study ID # TTP Peds Cardiac
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2020

Study information

Verified date September 2021
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 31, 2020
Est. primary completion date November 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Congenital Heart Surgery Exclusion Criteria: - Over 18

Study Design


Intervention

Other:
Transverse Thoracic Plane Block
A bilateral plane block in the transverse thoracic space

Locations

Country Name City State
United States Ochsner Health System New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Extubation The amount of time until the patients are extubated in the ICU or OR. 2 years
Secondary Surgical Stress Response HR response to incision 2 years
Secondary Opiate Usage Amount of total opiates used for the heart surgery 2 years
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