Different Type Ultrasound Guided Epidural Block Methods

NCT04222192 — Not applicable, Completed, 90 participants, Bursa Yuksek Ihtisas Training and Research Hospital

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

Registry	NCT04222192
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, basic science
Enrollment	90 (Actual)
Sponsor	Bursa Yuksek Ihtisas Training and Research Hospital (Other gov)
Conditions	Epidural Anesthesia, Ultrasound
Interventions	Epidural block (Other)
Dates	start 2020-01-15, primary completion 2021-01-15, completion 2021-01-30, first posted 2020-01-09, last updated 2022-12-23
Locations	1 site in Turkey (Türkiye)

-Summary

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Conventional Epidural application	Sham comparator	Other: Epidural block	Epidural catheter insertions with conventional (anatomical landmarks use) method
Paramedian sagittal application	Active comparator	Other: Epidural block	Epidural catheter insertions with real time ultrasound guided Paramedian sagittal approach
Transverse Interlaminar application	Active comparator	Other: Epidural block	Epidural catheter insertions with real time ultrasound guided Transverse Interlaminar approach

Epidural block (Other): Epidural catheter insertions

+Outcome measures

Primary outcomes

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

Secondary outcomes

Epidural igne visibility degree [20 minutes]: 4 = Excellent visibility, 3 = Medium visibility, 2 = Weak visibility 1 = No visibility using a 4-point Likert scale by the practitioner
Difficulty of catheter placement [30 minutes]: Assessed by the Practitioner using a 10-point scale, 0: easiest, 10: hardest)
distance measurement of neuraxial structures [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)
Patient position [20 minutes]: Patient position during epidural placement Sitting Lateral

+Eligibility

Sex: All, ages: 25 Years to 85 Years

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

+Locations (1)

Facility	City	Country	Status
Bursa Yuksek Ihtisas Training and Research Hospital	Bursa	Turkey (Türkiye)

+Investigators

Korgün Ökmen, Assoc. PhD., Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital