Ultrasound-guided Combined Spinal-epidural Anesthesia: Pre-procedure Versus Real-time Scan

September 20, 2019 updated by: Tae Kyong Kim, Seoul National University Hospital

A Randomized Comparison of the Ultrasound-guided Combined Spinal-epidural Anesthesia Technique: Pre-procedure Scan Versus Real-time Scan

The investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing spinal/epidural combined anesthesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Traditionally, spinal/epidural combined anesthesia has been performed by palpation of the landmark like Tuffier's line. There are some studies that using ultrasound improves the success rate to regional anesthesia. There are two methods of using ultrasonography, 'Real-time scan' and 'Pre-procedure scan'. Direct comparison of these two methods is not yet studied. So investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Spinal/Epidural combined anesthesia is required.

Exclusion Criteria:

  • Skin infection or trauma
  • Abnormal coagulation lab
  • History of spine surgery
  • Pregnancy
  • Abnormal structure of spine

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pre-procedure
Confirmed landmark by ultrasound scan before procedure
Procedure: prescan ultrasonography
Applying realtime ultrasound before the combined anesthesia
ACTIVE_COMPARATOR: Real time
Confirmed landmark by ultrasound scan during procedure
Procedure: realtime ultrasonography
Applying realtime ultrasound during the combined anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of needle pass
Time Frame: intraoperative
Number of needle pass
intraoperative

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Tae Kyong Kim, Kim, SMG-SNU Boramae Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

November 15, 2019

Primary Completion (ANTICIPATED)

January 15, 2020

Study Completion (ANTICIPATED)

January 15, 2020

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 30-2018-81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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