Parasternal Blockade and Serum Lactate in Cardiac Surgery

July 18, 2024 updated by: GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

Serum Lactate in the Application of Parasternal Blockade in Trans and Post Anesthetic Stages in Cardiac Surgery

Serum lactate level is a key indicator of tissue perfusion. Parasternal blockade is associated with reduced postoperative inflammatory response by inhibiting stress response, leading to better outcomes. Elevated lactate levels help identify patients at risk of postoperative morbidity and mortality. This analytical cross-sectional study evaluated the association between parasternal blockade and serum lactate levels in patients undergoing elective cardiac surgery in 2022 at Specialty Hospital CMNO. Patients with and without parasternal block were compared for changes in serum lactate levels during and after anesthesia within the first 24 hours.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Serum lactate level is a crucial indicator of tissue perfusion. 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 the identification of patients at risk of postoperative morbidity and mortality.

Objective: To evaluate the association between parasternal blockade and serum lactate level in patients undergoing cardiac surgery, both trans and postanesthesia.

Materials and Methods: Analytical cross-sectional study in adult patients undergoing elective cardiac surgery during the year 2022 in Specialty Hospital CMNO, patients with and without application of parasternal block were analyzed, and it was associated with changes in serum lactate level trans and post anesthesia in the first 24 hours. Approval registration: R-2023-1301-024.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44329
        • Recruiting
        • Centro Médico Nacional de Occidente
        • Contact:

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 older than 18 years
  • Either sex
  • ASA II-III
  • Patients who underwent cardiac surgery with median sternotomy and use of cardiopulmonary bypass.

Exclusion 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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case group
with parasternal block
Procedure: Parasternal block
In the case-control groups, patients with elevated serum lactate levels above 2 mmol/L and those who remained below this limit will be identified.
Procedure: Requirement of total dose regarding fentanyl
In case-control groups, obtain measurement of total postoperative fentanyl requirement.
No Intervention: Control group
without parasternal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum lactate measurement
Time Frame: 24 hours postoperative
Elevated serum lactate levels above 2 mmol/L
24 hours postoperative

Collaborators and Investigators

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

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Alejandro Gonzalez, 3, IMSS

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, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parasternal Blockade 2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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