Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

December 19, 2019 updated by: Jin-Tae Kim, Seoul National University Hospital

Midline Versus Paramedian Approaches for Ultrasound-assisted Spinal Anesthesia: a Randomized Controlled Trial

Ultrasound has emerged as an useful tool for neuraxial blockade. The aim of this study is to compare the efficacy and safety between the midline approach and paramedian approach for ultrasound-assisted spinal anesthesia in adult patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia, with ASA physical status classification I, II, III

Exclusion Criteria:

  • Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
  • Patients with morbid cardiac diseases
  • Pregnancy
  • Patients with previous history of lumbar spinal surgery
  • Patients with anatomical abnormality of lumbar spine

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Midline group
Preprocedural ultrasound-assisted midline approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Procedure: ultrasound-assisted midline approach
A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via midline approach.
ACTIVE_COMPARATOR: Paramedian group
Preprocedural ultrasound-assisted paramedian approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Procedure: ultrasound-assisted paramedian approach
A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via paramedian approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of needle passes
Time Frame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin
Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of spinal needle insertion attempts
Time Frame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
the number of times the spinal needle was withdrawn from the skin and reinserted
Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
Time taken for performing spinal anesthetic
Time Frame: Intraoperative (from insertion of the needle to the completion of injection)
time from needle insertion to the completion of injection
Intraoperative (from insertion of the needle to the completion of injection)
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle
Time Frame: Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure
Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
Periprocedural pain
Time Frame: Patients will be asked immediately after the completion of spinal anesthesia
11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Patients will be asked immediately after the completion of spinal anesthesia
Periprocedural discomfort score
Time Frame: Patients will be asked immediately after the completion of spinal anesthesia
11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Patients will be asked immediately after the completion of spinal anesthesia
Time for identifying landmarks
Time Frame: intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning
time from placement of the ultrasound probe on the skin to the completion of markings.
intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning
dermatome level of sensory block
Time Frame: 20 minutes after the completion of spinal anesthetic injection
thoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab
20 minutes after the completion of spinal anesthetic injection
Patient satisfaction score of spinal anesthesia procedure
Time Frame: Patients will be asked immediately after the completion of spinal anesthesia
11-point verbal rating scale (0=very unsatisfied, 10=very satisfied)
Patients will be asked immediately after the completion of spinal anesthesia

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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 (ACTUAL)

April 27, 2018

Primary Completion (ACTUAL)

October 8, 2018

Study Completion (ACTUAL)

October 9, 2018

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (ACTUAL)

April 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • H-1803-060-928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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