Bupivacaine Levels After ESPB

April 4, 2022 updated by: Onur Selvi, Maltepe University

Measurement of Bupivacaine Level Following ESPB (Erector Spinae Plane Block ) as a Part of Multimodal Analgesia

Erector Spinae Plane Block (ESPB) is a regional anesthesia technique that is used for as a part of multimodal analgesia. Bupivacaine is one of the local anesthetic drugs and it is applied for ESPB. In this study, it is aimed to examine its blood concentration following the application for ESPB regarding its adverse effects and pharmacokinetics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

ESPB is prefered block technique for thoraco abdominal surgeries. Bupivacaine is a widely used drug for these kind blocks.The systemic absorption rate of bupivacaine depends on the dose administered, the route of administration, and the vascularization of the injection site. The highest plasma concentration is achieved in intercostal blocks due to its rapid absorption (4 mg / liter after 400 mg dose).

The lowest plasma concentrations are seen in subcutaneous administration in the abdominal region. Total plasma clearance of bupivacaine was 0.58 L / min, steady state distribution volume was 73 liters, the elimination half-life was 2.7 hours and the hepatic extraction rate was 0.40. The maximum applicable legal dose varies by country. While it is 150 mg in Sweden, it is administered up to 400 mg in 24 hours in Finland. Clearance of bupivacaine has been shown to be lower in uremic patients. Plasma concentrations of highly proteing binding drugs are significantly effected by low cardiac output. The pharmacokinetics of many local anesthetics are influenced by inadequate liver function due to changes in body fluids and circulation. However, it seems safe in single dose blocks in patients with hepatic dysfunction. CYP2D6 enzyme inhibitors such as propranolol and CYP3A4 inhibitors such as itraconazole can reduce the clearance of bupivacaine by up to 30%.

As the concentration of local anesthetics including bupivacaine increases in systemic circulation, signs and symptoms of cardiovascular central nervous systems appear. The doses of bupivacaine that produce cardiovascular toxicity / central nervous system toxicity are similar. Stopping the administration of local anesthetics when early signs of the central nervous system observed does not prevent cardiotoxicity. Therefore, measurement of plasma levels of the drug may be important.

The blood level of bupivacaine is not routinely measured. Bupivacaine When the arterial plasma concentration is above 1.5 /g / ml, dizziness may occur, peripheral paresthesia above 2.0 /g / ml, and convulsions above 4.0 /g / ml. Intramuscular administration of 1.3 ug/kg causes psychomotor impairment in motor vehicle use. Dose-dependent central nervous system adverse effects are monitored and patient-related adverse event information is recorded. In a study in which toxic effects were observed with bupivacaine, which included 11,080 patients, the number of systemic toxicities was found to be 15 and none of them had permanent sequelae.

There are no reports on plasma bupivacaine levels in patients undergoing ESPB.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

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

  • Turkey
    • Maltepe
      • Istanbul, Maltepe, Turkey, 34843
        • Maltepe University Medical Faculty

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are already decided to be involved in Thoracoabdominal surgery who are decided to use bupivacaine with Erector spinae plane block before surgery for postoperative analgesia

Description

Incluson criteria:

  1. ESPB block receivers for thoracoabdominal surgeries
  2. Patients stratified according to ASA
  3. Female and male patients who underwent routine invasive arterial monitoring for additional diseases.
  4. Who approved informed consent

Exclusion criteria:

  1. Patients difficult to communicate
  2. Patients does not give consent
  3. uncontrolled hypertension
  4. Patients with the previous diagnosis of neurological and psychiatric diseases

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ESPB block group
Patients receiving ESPB will be enrolled to this group.
Drug: Bupivacaine
Measuring the plasma concentration level of bupivacaine after applying ESPB

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bupivacaine plasma concentration
Time Frame: 10 sampling in 720 minutes after application.
Determining plasma bupivacaine level after injection
10 sampling in 720 minutes after application.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maltepe University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01.10.2019 no 2

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.

Clinical Trials on Anesthesia

Clinical Trials on Bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings