Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

• ClinicalTrials.gov Identifier: NCT03491943
• Recruitment Status: Completed
• First Posted: April 9, 2018
• Last Update Posted: December 23, 2019
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Jin-Tae Kim, Seoul National University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia, Spinal; Ultrasonography	Procedure: ultrasound-assisted midline approach; Procedure: ultrasound-assisted paramedian approach	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Midline Versus Paramedian Approaches for Ultrasound-assisted Spinal Anesthesia: a Randomized Controlled Trial
• Actual Study Start Date: April 27, 2018
• Actual Primary Completion Date: October 8, 2018
• Actual Study Completion Date: October 9, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Midline group; 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; 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.
Active Comparator: Paramedian group; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. the number of needle passes [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

• Principal Investigator: Jin-Tae Kim, MD, PhD; Seoul National University Hospital

More Information

Publications:

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.

• Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03491943
• Other Study ID Numbers: H-1803-060-928
• First Posted: April 9, 2018
• Last Update Posted: December 23, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No