NCT04239053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

January 20, 2020

Last Update Submit

April 4, 2022

Conditions

AnesthesiaBupivacaine Adverse Reaction

Keywords

BupivacaineErector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

  • Bupivacaine plasma concentration

    Determining plasma bupivacaine level after injection

    10 sampling in 720 minutes after application.

Study Arms (1)

ESPB block group

Patients receiving ESPB will be enrolled to this group.

Drug: Bupivacaine

Interventions

BupivacaineDRUG

Measuring the plasma concentration level of bupivacaine after applying ESPB

ESPB block group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University Medical Faculty

Istanbul, Maltepe, 34843, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 23, 2020

Study Start

March 12, 2021

Primary Completion

May 15, 2021

Study Completion

March 17, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)