Pain, AcuteTTPPCTNCT04138745
Transverse Thoracic Plane Block in the Pediatric Cardiac Patient
An observational study of Pain, Acute and Congenital Heart Disease, run by Ochsner Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Congenital Heart Disease
- What is being tested?
- Transverse Thoracic Plane Block
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All comers int he age groups above
Who may be able to join
- Congenital Heart Surgery
Who cannot join
- Over 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain, Acute, Congenital Heart Disease
- Being tested
- Transverse Thoracic Plane Block
- Medical subject headings
- Acute Pain, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse Thoracic Plane BlockOther
A bilateral plane block in the transverse thoracic space
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transverse Thoracic Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation
The amount of time until the patients are extubated in the ICU or OR.
Measured: 2 years
Secondary outcomes (2)
Surgical Stress Response
HR response to incision
Measured: 2 years
Opiate Usage
Amount of total opiates used for the heart surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Jan 2018
- Primary completion1 Nov 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominic Carollo, Ochsner Health System
- Investigators
- DOMINIC S CAROLLO, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138745
- Sponsor's protocol ID
- TTP Peds Cardiac
- Acronym
- TTPPCT
- Status last verified
- Sep 2021
- First submitted
- 23 Oct 2019
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Thoracic Plane Block in the Pediatric Cardiac Patient
- ClinicalTrials.gov ID
- NCT04138745
- Acronym / sponsor ID
- TTPPCT / TTP Peds Cardiac
- Conditions
- Pain, Acute, Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Historical control patients that are matched to the surgery type |
| Experimental | – | Other: Transverse Thoracic Plane BlockAfter the practice change of TTP was initiated, the future pediatric patients were put into a database. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All comers int he age groups above
Key inclusion criteria (1 listed)
- Congenital Heart Surgery
Key exclusion criteria (1 listed)
- Over 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverse Thoracic Plane BlockA bilateral plane block in the transverse thoracic space | Other | Experimental |
Primary outcome
Extubation
Time frame: 2 years
The amount of time until the patients are extubated in the ICU or OR.
2 secondary outcomes
Surgical Stress Response
Time frame: 2 years
Opiate Usage
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DOMINIC S CAROLLO, MD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Acute and Congenital Heart Disease, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.