Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks

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. Identifier: NCT00956137
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : December 4, 2017
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Spinal anesthesia is the technique of choice in patients undergoing total joint arthroplasty at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of the lumbar vertebrae). These surface landmarks may be absent, indistinct or distorted in many of the patients presenting for total joint arthroplasty. This is because of obesity, previous spinal surgery, scoliosis and degenerative changes of aging. The investigators have shown in a previous study that a pre-procedural ultrasound scan of the spine can reliably identify an appropriate site for needle insertion in spinal anesthesia, and that this results in a high success rate on the first needle insertion attempt (84% vs 61-64% in published studies). The investigators therefore believe that this ultrasound-assisted technique of spinal anesthesia is extremely useful, especially in patients with poor-quality surface landmarks. However there are no published randomized controlled trials to date that compare the efficacy of the ultrasound-assisted technique with the traditional surface landmark-guided technique of spinal anesthesia.

Condition or disease Intervention/treatment Phase
Spinal Anesthesia Procedure: Ultrasound guidance Procedure: Manual palpation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks.
Study Start Date : May 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultrasound
Use of ultrasound to identify vertebral interspaces for needle insertion.
Procedure: Ultrasound guidance
ultrasound imaging
Active Comparator: Palpation
Use of manual palpation to identify vertebral landmarks and vertebral interspaces for needle insertion.
Procedure: Manual palpation
Manual Palpation of vertebra

Primary Outcome Measures :
  1. The success rate of dural puncture on the first needle insertion attempt. [ Time Frame: within 2 hours prior to surgery ]

Secondary Outcome Measures :
  1. number of needle insertions/re-directions; performance time; Pain score; Patient satisfaction; quality of ultrasound image; Correlation between palpation and ultrasound; Correlation between ultrasound and measured depth to i.t. space [ Time Frame: within 2 hours prior to surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Planned spinal anesthesia for elective lower limb surgery; and one or more of the following:

    1. Body mass index ≥ 35 kgm-2
    2. Scoliosis or other spinal deformity
    3. Poorly palpable or impalpable spinous processes

Exclusion Criteria:

  • Patient refusal
  • Contra-indications to regional anesthesia
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Inability to provide informed consent

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 identifier (NCT number): NCT00956137

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Ki Jinn Chin, MD University Health Network, Toronto

Responsible Party: University Health Network, Toronto Identifier: NCT00956137     History of Changes
Other Study ID Numbers: 09-0190-AE
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: January 2010

Keywords provided by University Health Network, Toronto:
spinal anesthesia
intervertebral space

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs