Different Type Ultrasound Guided Epidural Block Methods

December 21, 2022 updated by: Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Evaluation of Different Type Ultrasound Guided Epidural Block Methods ; Paramedian Sagittal and Transverse Interlaminar View

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

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
      • Bursa, Turkey, 16110
        • Bursa Yuksek Ihtisas Training and Research Hospital

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

Ages Eligible for Study

21 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Conventional Epidural application
Epidural catheter insertions with conventional (anatomical landmarks use) method
Other: Epidural block
Epidural catheter insertions
Active Comparator: Paramedian sagittal application
Epidural catheter insertions with real time ultrasound guided Paramedian sagittal approach
Other: Epidural block
Epidural catheter insertions
Active Comparator: Transverse Interlaminar application
Epidural catheter insertions with real time ultrasound guided Transverse Interlaminar approach
Other: Epidural block
Epidural catheter insertions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of needle routing
Time Frame: 20 minutes
number of needle redirects forming successful block
20 minutes
Epidural catheter placement time
Time Frame: 20 minutes
time (minutes) until the epidural catheter is inserted
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidural igne visibility degree
Time Frame: 20 minutes
4 = Excellent visibility, 3 = Medium visibility, 2 = Weak visibility 1 = No visibility using a 4-point Likert scale by the practitioner
20 minutes
Difficulty of catheter placement
Time Frame: 30 minutes
Assessed by the Practitioner using a 10-point scale, 0: easiest, 10: hardest)
30 minutes
distance measurement of neuraxial structures
Time Frame: 30 minutes

Anterior and posterior complex distance measured during epidural administration.

Distance from skin to anterior aspect of ligament flavum (cm)

Distance from skin to posterior dura (cm)
30 minutes
Patient position
Time Frame: 20 minutes
Patient position during epidural placement Sitting Lateral
20 minutes

Collaborators and Investigators

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

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Principal Investigator: Korgün Ökmen, Assoc. PhD., Bursa Yuksek Ihtisas Training and Research Hospital

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)

January 15, 2020

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

January 4, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Estimate)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-KAEK-25 2019/12-09

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.

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