Different Type Ultrasound Guided Epidural Block Methods

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: Ultrasound; Epidural Anesthesia
• Intervention / Treatment: Other: Epidural block

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	number of needle redirects forming successful block	20 minutes
Epidural catheter placement time	time (minutes) until the epidural catheter is inserted	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural igne visibility degree	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	Assessed by the Practitioner using a 10-point scale, 0: easiest, 10: hardest)	30 minutes
distance measurement of neuraxial structures	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	Patient position during epidural placement Sitting Lateral	20 minutes

Collaborators and Investigators

• 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

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