Clinical Trials Directory

Trials / Completed

CompletedNCT03316352

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasound-assisted paramedian technique spinal anesthesiaUltrasound-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.
PROCEDURELandmark-guided paramedian technique spinal anesthesiaLandmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.
DEVICEUltrasoundA 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).
DRUG0.5% heavy bupivacaineDuring 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.

Timeline

Start date
2017-10-24
Primary completion
2018-01-11
Completion
2018-01-11
First posted
2017-10-20
Last updated
2018-08-31

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03316352. Inclusion in this directory is not an endorsement.