Ultrasound for Neuraxial Anesthesia

July 5, 2019 updated by: Georgios Kotsovolis, 424 General Military Hospital

Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia

The patients will be allocated to 2 groups: the ultrasound group and the palpation group. Ultrasound detection of the puncture site will be performed to the patients of the one group (group U). The puncture site will be determined by palpation of the landmarks at the patients of the other group (group L). The main purpose of the study is to determine if the ultrasound scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural anesthesia, increase the success and decrease the complication rate of these techniques. The secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to determine accurately the depth of the epidural space.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 56429
        • 424 Army General Hospital Department of Anesthesia

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgery under spinal, epidural or combined spinal-epidural anesthesia.
  • Surgery under general anesthesia and preoperative placement of epidural catheter for postoperative analgesia.
  • ASA 1-3.

Exclusion Criteria:

  • History of lumbar spinal surgery.
  • Low back pain at the time of anesthesia

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ultrasound
Device: Detection of the puncture site by ultrasound scan of the lumbar spine.
Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The scanning will be performed as described by Arzola et al. The L3-L4 space will be identified by palpation and identification of the landmarks (Tuffier's line). The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified (bright signal followed by dark triangular area). The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site. The distance from the skin to the ligamentum flavum will be measured by the ultrasound caliper.
ACTIVE_COMPARATOR: Landmarks
Procedure: Detection of the puncture site by identification of the landmarks.
Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Successful Techniques
Time Frame: An expected average of 10 minutes after the technique.
For spinal and epidural anesthesia, success of the technique is defined as the installation of sensory block before surgery. For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.
An expected average of 10 minutes after the technique.
Number of Participants With Success of the Technique at the First Attempt
Time Frame: An expected average of 10 minutes after the technique.
Number of patients with completion of the technique without any withdrawal or reposition of the needle.
An expected average of 10 minutes after the technique.
Number of Attempts Required.
Time Frame: An expected average of 10 minutes after the technique..
How many times did the operator withdraw the needle and repeated the puncture.
An expected average of 10 minutes after the technique..
Repositioning Frequency.
Time Frame: An expected average of 10 minutes after the technique.
How many times did the operator change the trajectory of the needle.
An expected average of 10 minutes after the technique.
Number of Participants With Change of the Intervertebral Space.
Time Frame: An expected average of 10 minutes after the technique.
Number of patients to whom the operator had to perform the puncture at a different intervertebral place than the initial one.
An expected average of 10 minutes after the technique.
Time Required.
Time Frame: An expected average of 15 minutes.
Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia
An expected average of 15 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depth of the Epidural Space Measured by Ultrasound.
Time Frame: An expected average of 3 minutes after the beginning of the procedure.
The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper.
An expected average of 3 minutes after the beginning of the procedure.
Depth of the Epidural Space Measured by the Needle.
Time Frame: An expected average of 5 minutes after the beginning of the procedure.
The distance between the skin and the ligamentum flavum measured by the markers on the Tuohy needle.
An expected average of 5 minutes after the beginning of the procedure.
Number of Patients With Low Back Pain.
Time Frame: 12hours and 24hours after the end of the technique.
Number of patients who reported low back pain after the technique.
12hours and 24hours after the end of the technique.
Low Back Pain Intensity.
Time Frame: 12hours and 24hours after the end of the technique.
The patient is asked to evaluate the lumbar pain by the 11scale Numerical Rating Scale (0 no pain, 10 maximum possible pain).
12hours and 24hours after the end of the technique.
Patient Satisfaction.
Time Frame: 12hours after the end of the technique.
The patient is asked if he is satisfied with the technique (Definitely not, Not completely, Yes) and if he would choose the same technique in the future (Yes/No).
12hours after the end of the technique.
Number of Participants With Any Complication.
Time Frame: 24hours after the end of the technique.
Number of patients who had any complication after the technique
24hours after the end of the technique.

Collaborators and Investigators

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

Sponsor

424 General Military Hospital

Investigators

  • Principal Investigator: Georgios Kotsovolis, 424 Army General Hospital of Thessaloniki

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

September 1, 2015

Primary Completion (ACTUAL)

January 10, 2018

Study Completion (ACTUAL)

January 10, 2018

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (ESTIMATE)

September 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14073

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.

Clinical Trials on Lumbar Ultrasound

Clinical Trials on Detection of the puncture site by ultrasound scan of the lumbar spine.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe