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

NCT03316352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-08-31

No results posted yet for this study

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

  • Anesthesia, Spinal
  • Ultrasonography

Interventions

PROCEDURE

Ultrasound-assisted paramedian technique spinal anesthesia

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.

PROCEDURE

Landmark-guided paramedian technique spinal anesthesia

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

DEVICE

Ultrasound

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).

DRUG

0.5% heavy bupivacaine

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.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jin-Tae Kim, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2018-01-11
Completion
2018-01-11

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03316352 on ClinicalTrials.gov