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Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491943
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, 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.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491943


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, MD, PhD Seoul National University Hospital

Publications:
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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    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs