Different Type Ultrasound Guided Epidural Block Methods

NCT ID: NCT04222192

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The nerve blocks applied with ultrasonography are used for pain and operation after many operations today.

Applications with ultrasonography shorten the processing time, reduce the amount of local anesthetic used and lead to fewer complications.

However, the use of ultrasonography is not so common in neuraxial regional anesthesia applications. In the literature, epidural applications accompanied by ultrasonography were applied with different approaches.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study the investigators will used the two different ultrasound -guided epidural block approach .

Paramedian sagittal oblique and Transverse interlaminar. The investigators will used this two technique in epidural catheter placement using the real-time ultrasound.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epidural Anesthesia Ultrasound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional Epidural application

Epidural catheter insertions with conventional (anatomical landmarks use) method

Group Type SHAM_COMPARATOR

Epidural block

Intervention Type OTHER

Epidural catheter insertions

Paramedian sagittal application

Epidural catheter insertions with real time ultrasound guided Paramedian sagittal approach

Group Type ACTIVE_COMPARATOR

Epidural block

Intervention Type OTHER

Epidural catheter insertions

Transverse Interlaminar application

Epidural catheter insertions with real time ultrasound guided Transverse Interlaminar approach

Group Type ACTIVE_COMPARATOR

Epidural block

Intervention Type OTHER

Epidural catheter insertions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Epidural block

Epidural catheter insertions

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Patients whom need medical epidural anesthesia
* Patients with consent to participate in the study

Exclusion Criteria

* Patients with a known history of back surgery
* Bleeding diathesis disorder
* Allergy to local anesthetics
* Patient refusal
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Korgün Ökmen

Principal Investigator ,Assoc. PhD. M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Korgün Ökmen, Assoc. PhD.

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-KAEK-25 2019/12-09

Identifier Type: -

Identifier Source: org_study_id