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Completed

NCT Number: NCT03316352

Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients

Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.

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Key information

Conditions

Anesthesia, Spinal Ultrasonography

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elderly patients (age≥60 years) scheduled to undergoing elective orthopedic surgery under spinal anesthesia
  • Patients 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 spine surgery

Treatment and study plan

Ultrasound-assisted paramedian technique spinal anesthesia

Procedure

Ultrasound-assisted paramedian technique will be used. A preprocedural ultrasound scan will be performed, and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be done according to skin marking using ultrasound, via paramedian approach.

Other names: sono-assisted

Landmark-guided paramedian technique spinal anesthesia

Procedure

Landmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.

Other names: conventional

Ultrasound

Device

A preprocedural ultrasound scan will be done using Portable Echocardiography system (Vivid-i, GE healthcare) with 4C-RS convex probe (2.0-5.5 MHz Frequency range).

Other names: sonography

0.5% heavy bupivacaine

Drug

During spinal anesthesia, 0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.

Other names: bupivacaine

Primary outcomes

  1. the number of needle passes

    Time frame: from the initiation of spinal anesthesia procedure, 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: from the initiation of spinal anesthesia procedure, 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: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

    In group L, time from start of palpation to completion of the process, as declared by the anesthesiologist. In group U, time from placement of the ultrasound probe on the skin to the completion of markings.

  3. Time taken for performing spinal anesthetic

    Time frame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

    time from needle insertion to the completion of injection

  4. Level of block

    Time frame: 5, 10, 15 minutes after the completion of spinal anesthetic injection

    loss of cold sensation tested with 2% chlorhexidine swab

  5. Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle

    Time frame: from the initiation of spinal anesthesia procedure, 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: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

    11-point verbal rating scale (0=no pain, 10=most pain imaginable)

  7. Periprocedural discomfort score

    Time frame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

    11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2017
Registry last updated
Aug 31, 2018

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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