NCT04222192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

January 4, 2020

Last Update Submit

December 21, 2022

Conditions

Epidural AnesthesiaUltrasound

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Epidural igne visibility degree

    20 minutes

  • Difficulty of catheter placement

    30 minutes

  • distance measurement of neuraxial structures

    30 minutes

  • Patient position

    20 minutes

Study Arms (3)

Conventional Epidural application

SHAM COMPARATOR

Epidural catheter insertions with conventional (anatomical landmarks use) method

Other: Epidural block

Paramedian sagittal application

ACTIVE COMPARATOR

Epidural catheter insertions with real time ultrasound guided Paramedian sagittal approach

Other: Epidural block

Transverse Interlaminar application

ACTIVE COMPARATOR

Epidural catheter insertions with real time ultrasound guided Transverse Interlaminar approach

Other: Epidural block

Interventions

Epidural blockOTHER

Epidural catheter insertions

Conventional Epidural applicationParamedian sagittal applicationTransverse Interlaminar application

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a known history of back surgery
  • Bleeding diathesis disorder
  • Allergy to local anesthetics
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Korgün Ökmen, Assoc. PhD.

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator ,Assoc. PhD. M.D.

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 9, 2020

Study Start

January 15, 2020

Primary Completion

January 15, 2021

Study Completion

January 30, 2021

Last Updated

December 23, 2022

Record last verified: 2022-12

Locations

TU(1)