Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

N/ACompletedNCT03491943

Seoul National University Hospital112 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

112

Conditions

Anesthesia, Spinal Ultrasonography

Interventions

ultrasound-assisted midline approachPROCEDURE

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.

ultrasound-assisted paramedian approachPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

the number of needle passes

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

Time frame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)

Secondary Outcomes

Number of spinal needle insertion attempts

the number of times the spinal needle was withdrawn from the skin and reinserted

Time frame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)

Time for identifying landmarks

time from placement of the ultrasound probe on the skin to the completion of markings.

Time frame: intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning

Time taken for performing spinal anesthetic

time from needle insertion to the completion of injection

Time frame: Intraoperative (from insertion of the needle to the completion of injection)

dermatome level of sensory block

thoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab

Time frame: 20 minutes after the completion of spinal anesthetic injection

Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle

Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure

Time frame: Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)

Data from ClinicalTrials.gov

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