Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00956137
First received: July 17, 2009
Last updated: January 22, 2010
Last verified: January 2010
  Purpose

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 Intervention
Spinal Anesthesia
Procedure: Ultrasound guidance
Procedure: Manual palpation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks.

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The success rate of dural puncture on the first needle insertion attempt. [ Time Frame: within 2 hours prior to surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: May 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956137

Contacts
Contact: Ki Jinn Chin, MD 416 603-5118 kijinn.chin@uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Alex Kerr, BSc    416 603-5800 ext 6237    alex.kerr@uhn.on.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Ki Jinn Chin, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Ki Jinn Chin, University Health Network
ClinicalTrials.gov Identifier: NCT00956137     History of Changes
Other Study ID Numbers: 09-0190-AE
Study First Received: July 17, 2009
Last Updated: January 22, 2010
Health Authority: Canada: Canadian REB

Keywords provided by University Health Network, Toronto:
spinal anesthesia
ultrasound
palpation
knee
hip
surgery
intervertebral space

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014