Bupivacaine Levels After ESPB

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: Completed
• Conditions: Anesthesia; Bupivacaine Adverse Reaction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bupivacaine plasma concentration	Determining plasma bupivacaine level after injection	10 sampling in 720 minutes after application.

Collaborators and Investigators

• Sponsor: Maltepe University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): March 17, 2022

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Bupivacaine; Erector Spinae Plane Block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID 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