Paraesternal Blockade and Lactate Serum Levels in Patients with Cardiac Surgery.

September 20, 2024 updated by: Clotilde Fuentes-Orozco, Instituto Mexicano del Seguro Social

Association Between the Application of Parasternal Blockade and Serum Lactate Level in Trans and Post-anesthetic Stages in Cardiac Surgery.

Parasternal blockade has been related to a reduction of the postoperative inflammatory response, by inhibition of the stress response, leading to a better prognosis. Increased lactate level is a useful parameter in identifying patients at risk of postoperative morbidity and mortality. The objective was to evaluate the association between parasternal blockade and serum lactate level in patients undergoing cardiac surgery, both trans- and post-anesthesia. 86 patients between 60-70 years of age participated. An association was found between the application of parasternal blockade in cardiac surgery and the presence of lower trans and postanesthetic serum lactate levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An analytical cross-sectional study in adult patients who underwent elective cardiac surgery. A total sample of 86 patients was obtained, 43 in the case group and 43 in the control group. Adult patients older than 18 years, of either sex, with ASA II-III, patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass were included.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44329
        • Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, México

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Adult patients over 18 years of age
  • Either sex
  • ASA II-IV
  • Patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass.

Elimination criteria

- Patients with pre-existing conditions that could independently affect serum lactate levels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blockade
In patients which parasternal block has been applied
Diagnostic test: Lactate serum level
Blood samples were taken to identify serum lactate levels greater than 2 mmol/l and those that remained below this limit.
Procedure: parasternal block
Administration of parasternal block with ropivacaine, bilaterally at the sternum before the start of surgery.
Experimental: Control
In patients which parasternal block has not been applied
Diagnostic test: Lactate serum level
Blood samples were taken to identify serum lactate levels greater than 2 mmol/l and those that remained below this limit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate serum levels
Time Frame: 24 Hours
Blood samples were taken to identify serum lactate levels greater than 2 mmol/l and those that remained below this limit.
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

September 2, 2024

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-2023-1301-024.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a closed study completed at a single center.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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