Left Ventricular DysfunctionNCT05650008
Effects of Intrathecal Local Anesthetics on Left Ventricular Global Longitudinal Strain
An observational study of Left Ventricular Dysfunction and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The objective of this study is to assess the effects of intrathecal local anesthetics on left ventricular global longitudinal strain (LVGLS) using transthoracic echocardiography (TTE). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Dysfunction, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Global Cardiac Wall Motion Dysfunction
- What is being tested?
- Intrathecal local anesthesia
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 10 Oct 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with no known history of LV dysfunction undergoing elective surgery under spinal anesthesia.
Who may be able to join
- Adult patients undergoing elective knee and hip replacements under spinal anesthesia
Who cannot join
- Patients who do not wish to consent
- Patients with contraindications to TTE
- Patients with reduced left ventricular systolic function as defined by LV ejection fraction < 50% on pre-operative echocardiography
- Patients with body mass index greater than 40
- Non-English-speaking subjects
- Cognitively impaired adults
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The objective of this study is to assess the effects of intrathecal local anesthetics on left ventricular global longitudinal strain (LVGLS) using transthoracic echocardiography (TTE).
- Conditions
- Left Ventricular Dysfunction, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Global Cardiac Wall Motion Dysfunction
- Being tested
- Intrathecal local anesthesia
- Keywords
- Strain
- Medical subject headings
- Ventricular Dysfunction, Left, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal local anesthesiaDrug
Also called Spinal anesthesia
Administration of local anesthetic into intrathecal space to achieve surgical anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Global Longitudinal Strain
Measured: 5 minutes
Secondary outcomes (1)
Left Ventricular Ejection Fraction
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Feb 2023
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shayne Michael Roberts, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650008
- Sponsor's protocol ID
- 21263
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intrathecal Local Anesthetics on Left Ventricular Global Longitudinal Strain
- ClinicalTrials.gov ID
- NCT05650008
- Acronym / sponsor ID
- 21263
- Conditions
- Left Ventricular Dysfunction, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Global Cardiac Wall Motion Dysfunction
- Keywords
- Strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 14 Dec 2022 (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.
The objective of this study is to assess the effects of intrathecal local anesthetics on left ventricular global longitudinal strain (LVGLS) using transthoracic echocardiography (TTE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with no known history of LV dysfunction undergoing elective surgery under spinal anesthesia.
Key inclusion criteria (1 listed)
- Adult patients undergoing elective knee and hip replacements under spinal anesthesia
Key exclusion criteria (6 listed)
- Patients who do not wish to consent
- Patients with contraindications to TTE
- Patients with reduced left ventricular systolic function as defined by LV ejection fraction < 50% on pre-operative echocardiography
- Patients with body mass index greater than 40
- Non-English-speaking subjects
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 |
|---|---|---|
| Intrathecal local anesthesiaAlso: Spinal anesthesiaAdministration of local anesthetic into intrathecal space to achieve surgical anesthesia | Drug | – |
Primary outcome
Left Ventricular Global Longitudinal Strain
Time frame: 5 minutes
1 secondary outcome
Left Ventricular Ejection Fraction
Time frame: 5 minutes
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 24 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Left Ventricular Dysfunction and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Milton S. Hershey Medical Center 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 6 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 24 Nov 2023. 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?
Left Ventricular Global Longitudinal Strain (time frame: 5 minutes). 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 24 Nov 2023.