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NCT Number: NCT03459105

Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy

Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.

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Key information

Conditions

Anesthesia, Spinal Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases 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,
  • and with (1) or (2)
  • documented scoliosis in preoperative L-S-Spine X-ray (Cobb abgle > 10 degree)
  • previous history of lumbar spinal surgery

Exclusion criteria

  • Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
  • Patients with morbid cardiac diseases
  • Pregnancy

Treatment and study plan

Ultrasound-assisted paramedian spinal anesthesia

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.

Other names: sono-assisted

Landmark-Guided Spinal Anesthesia

Procedure

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

Other names: conventional

0.5% heavy bupivacaine

Drug

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: 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: 1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/scanning)

    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: 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: 5, 10, 15 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
Jan 3, 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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