Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491943
• Other study ID #: H-1803-060-928
• Status: Completed
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: October 9, 2018

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 9, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Ultrasonography

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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):1089-96. doi: 10.1213/ANE.0000000000000911. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of spinal needle insertion attempts	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)
Secondary	Time for identifying landmarks	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
Secondary	Time taken for performing spinal anesthetic	time from needle insertion to the completion of injection	Intraoperative (from insertion of the needle to the completion of injection)
Secondary	dermatome level of sensory block	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
Secondary	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	Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
Secondary	Periprocedural pain	11-point verbal rating scale (0=no pain, 10=most pain imaginable)	Patients will be asked immediately after the completion of spinal anesthesia
Secondary	Periprocedural discomfort score	11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)	Patients will be asked immediately after the completion of spinal anesthesia
Secondary	Patient satisfaction score of spinal anesthesia procedure	11-point verbal rating scale (0=very unsatisfied, 10=very satisfied)	Patients will be asked immediately after the completion of spinal anesthesia