Bupivacaine Levels After ESPB

Sponsor

Maltepe University (Other)

Overall Status

Completed

CT.gov ID

NCT04239053

Collaborator

(none)

Enrollment

Location

12.2

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Bupivacaine Adverse Reaction	Drug: Bupivacaine

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 Design

Study Type:

Observational

Actual Enrollment :

17 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 12, 2021

Actual Primary Completion Date :

May 15, 2021

Actual Study Completion Date :

Mar 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
ESPB block group Patients receiving ESPB will be enrolled to this group.	Drug: Bupivacaine Measuring the plasma concentration level of bupivacaine after applying ESPB

Arm

Intervention/Treatment

ESPB block group

Patients receiving ESPB will be enrolled to this group.

Drug: Bupivacaine

Measuring the plasma concentration level of bupivacaine after applying ESPB

Outcome Measures

Primary Outcome Measures

Bupivacaine plasma concentration [10 sampling in 720 minutes after application.]
Determining plasma bupivacaine level after injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Incluson criteria:

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

Exclusion criteria:

Patients difficult to communicate
Patients does not give consent
uncontrolled hypertension
Patients with the previous diagnosis of neurological and psychiatric diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maltepe University Medical Faculty	Istanbul	Maltepe	Turkey	34843

Sponsors and Collaborators

Maltepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Onur Selvi, Associate professor, Maltepe University

ClinicalTrials.gov Identifier:

NCT04239053

Other Study ID Numbers:

01.10.2019 no 2

First Posted:

Jan 23, 2020

Last Update Posted:

Apr 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Onur Selvi, Associate professor, Maltepe University

Bupivacaine

Erector Spinae Plane Block

Additional relevant MeSH terms:

Bupivacaine

Study Results

No Results Posted as of Apr 5, 2022