Clinical trial NCT03491943: Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia
Official title: Midline Versus Paramedian Approaches for Ultrasound-assisted Spinal Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Ultrasonography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: the number of needle passes
timeFrame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
Secondary outcomes:
measure: Number of spinal needle insertion attempts
timeFrame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
measure: Time for identifying landmarks
timeFrame: intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning
measure: Time taken for performing spinal anesthetic
timeFrame: Intraoperative (from insertion of the needle to the completion of injection)
measure: dermatome level of sensory block
timeFrame: 20 minutes after the completion of spinal anesthetic injection
measure: Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle
timeFrame: Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
measure: Periprocedural pain
timeFrame: Patients will be asked immediately after the completion of spinal anesthesia
measure: Periprocedural discomfort score
timeFrame: Patients will be asked immediately after the completion of spinal anesthesia
measure: Patient satisfaction score of spinal anesthesia procedure
timeFrame: Patients will be asked immediately after the completion of spinal anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kallidaikurichi Srinivasan K, Iohom G, Loughnane F, Lee PJ. Conventional Landmark-Guided Midline Versus Preprocedure Ultrasound-Guided Paramedian Techniques in Spinal Anesthesia. Anesth Analg. 2015 Oct;121(4):1089-1096. doi: 10.1213/ANE.0000000000000911.
citation: Park SK, Cheun H, Kim YW, Bae J, Yoo S, Kim WH, Lim YJ, Kim JT. Ultrasound-assisted spinal anesthesia: A randomized comparison between midline and paramedian approaches. J Clin Anesth. 2022 Sep;80:110823. doi: 10.1016/j.jclinane.2022.110823. Epub 2022 Apr 11.