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Completed

NCT Number: NCT03491943

Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia

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.

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Key information

Conditions

Anesthesia, Spinal Ultrasonography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 9, 2018
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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