Effects of Intrathecal Local Anesthetics on Left Ventricu... | NCT05650008

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Oct 10, 2023Actual

Completion Date

Oct 10, 2023Actual

First Submitted Date

Dec 6, 2022

First Submission Date that Met QC Criteria

Dec 6, 2022

First Posted Date

Dec 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2023

Last Update Posted Date

Nov 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shayne Michael Roberts, Associate Professor, Department of Anesthesiology and Perioperative Medicine, Milton S. Hershey Medical CenterPrincipal Investigator

Lead Sponsor

Milton S. Hershey Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intrathecal local anesthesia	Drug	Administration of local anesthetic into intrathecal space to achieve surgical anesthesia		Spinal anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left Ventricular Global Longitudinal Strain		5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Left Ventricular Ejection Fraction		5 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients undergoing elective knee and hip replacements under spinal anesthesia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with no known history of LV dysfunction undergoing elective surgery under spinal anesthesia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Milton S. Hershey Medical Center		Hershey	Pennsylvania	17033	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D018487	Ventricular Dysfunction, Left
D013180	Sprains and Strains

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014947	Wounds and Injuries

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia