CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
0.5% heavy bupivacaine +3 moredrug
Likely dose
0.5% heavy bupivacaine 16 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03316352
NCT03316352N/ACompleted

Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients

Seoul National University Hospital·interventional·Posted Oct 20, 2017·Updated Aug 31, 2018

In Brief

A clinical study evaluating Ultrasound-assisted paramedian technique spinal anesthesia, Landmark-guided paramedian technique spinal anesthesia, and 2 other interventions for Anesthesia, Spinal and Ultrasonography. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 20, 2017
Enrollment StartOct 24, 2017
Primary CompletionJan 11, 2018
TodayJul 1, 2026
Enrollment to primary: 3 monthsPosted 8.7 years ago

Interventions

Ultrasound-assisted paramedian technique spinal anesthesiaprocedure

Ultrasound-assisted paramedian technique will be used. A preprocedural ultrasound scan will be performed, and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be done according to skin marking using ultrasound, via paramedian approach.

Landmark-guided paramedian technique spinal anesthesiaprocedure

Landmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.

Ultrasounddevice

A preprocedural ultrasound scan will be done using Portable Echocardiography system (Vivid-i, GE healthcare) with 4C-RS convex probe (2.0-5.5 MHz Frequency range).

0.5% heavy bupivacainedrug

During spinal anesthesia, 0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.