Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia, Spinal; Ultrasonography
• Interventions: Procedure: ultrasound-assisted midline approach; Procedure: ultrasound-assisted paramedian approach

• Registration Number: NCT03491943
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-09
• Study Start: 2018-04-27
• Primary Completion: 2018-10-08
• Study Completion: 2018-10-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midline group	ultrasound-assisted midline approach	Preprocedural ultrasound-assisted midline approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Paramedian group	ultrasound-assisted paramedian approach	Preprocedural ultrasound-assisted paramedian approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
the number of needle passes	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

Secondary Outcome Measures

Name	Time	Method
Number of spinal needle insertion attempts	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
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)	Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure
Time for identifying landmarks	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.
Time taken for performing spinal anesthetic	Intraoperative (from insertion of the needle to the completion of injection)	time from needle insertion to the completion of injection
dermatome level of sensory block	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
Periprocedural pain	Patients will be asked immediately after the completion of spinal anesthesia	11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Periprocedural discomfort score	Patients will be asked immediately after the completion of spinal anesthesia	11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Patient satisfaction score of spinal anesthesia procedure	Patients will be asked immediately after the completion of spinal anesthesia	11-point verbal rating scale (0=very unsatisfied, 10=very satisfied)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of