Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks
Recruitment status was Recruiting
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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. |
- 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 ]
- 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 |
Inclusion Criteria:
Planned spinal anesthesia for elective lower limb surgery; and one or more of the following:
- Body mass index ≥ 35 kgm-2
- Scoliosis or other spinal deformity
- 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| Contact: Ki Jinn Chin, MD | 416 603-5118 | kijinn.chin@uhn.on.ca |
| 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 | |
| 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 May 19, 2013