CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 146 enrolled
Drug / intervention
Detection of the puncture site by ultrasound scan of the lumbar spine. +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT02553746
NCT02553746N/ACompleted

Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia

424 General Military Hospital·interventional·Posted Sep 18, 2015·Updated Aug 12, 2019

In Brief

A clinical study evaluating Detection of the puncture site by ultrasound scan of the lumbar spine. and Detection of the puncture site by identification of the landmarks. for Lumbar Ultrasound. Completed, enrolled 146 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 18, 2015
Enrollment StartSep 1, 2015
Primary CompletionJan 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.8 years ago

Interventions

Detection of the puncture site by ultrasound scan of the lumbar spine.device

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.

Detection of the puncture site by identification of the landmarks.procedure

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.