Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

NCT03491943 | Completed

• 1 other identifier: H-1803-060-928
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Spinal; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (8)

• Number of spinal needle insertion attempts

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

• Time for identifying landmarks

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

• Time taken for performing spinal anesthetic

  Intraoperative (from insertion of the needle to the completion of injection)

• dermatome level of sensory block

  20 minutes after the completion of spinal anesthetic injection

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

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

Study Arms (2)

Midline group

EXPERIMENTAL

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

Paramedian group

ACTIVE COMPARATOR

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

Interventions

ultrasound-assisted midline approach PROCEDURE

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.

Midline group

ultrasound-assisted paramedian approach PROCEDURE

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.

Paramedian group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (2)

• 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.

  PMID: 26270115 BACKGROUND

• 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.

  PMID: 35421679 DERIVED

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: April 27, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 9, 2018
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)