Different Type Ultrasound Guided Epidural Block Methods

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04222192
• Collaborator: (none)
• Enrollment: 90
• Arms: 3
• Anticipated Duration (Months): 12.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Epidural Anesthesia; Ultrasound	Other: Epidural block	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Evaluation of Different Type Ultrasound Guided Epidural Block Methods ; Paramedian Sagittal and Transverse Interlaminar View
• Anticipated Study Start Date: Jan 15, 2020
• Anticipated Primary Completion Date: Jan 15, 2021
• Anticipated Study Completion Date: Jan 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of needle routing [20 minutes]

   number of needle redirects forming successful block

2. Epidural catheter placement time [20 minutes]

   time (minutes) until the epidural catheter is inserted

Secondary Outcome Measures

1. 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

2. Difficulty of catheter placement [30 minutes]

   Assessed by the Practitioner using a 10-point scale, 0: easiest, 10: hardest)

3. 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)

4. Patient position [20 minutes]

   Patient position during epidural placement Sitting Lateral

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bursa Yüksek İhtisas Education and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Korgün Ökmen, Principal Investigator ,Assoc. PhD. M.D., Bursa Yüksek İhtisas Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT04222192
• Other Study ID Numbers: 2011-KAEK-25 2019/12-09
• First Posted: Jan 9, 2020
• Last Update Posted: Jan 13, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 13, 2020