Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks

Not Applicable

Completed

• Conditions: Spinal Anesthesia
• Interventions: Procedure: Ultrasound guidance; Procedure: Manual palpation

• Registration Number: NCT00956137
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-11
• Status Verified: 2010-01
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound guidance	Use of ultrasound to identify vertebral interspaces for needle insertion.
Palpation	Manual palpation	Use of manual palpation to identify vertebral landmarks and vertebral interspaces for needle insertion.

Primary Outcome Measures

Name	Time	Method
The success rate of dural puncture on the first needle insertion attempt.	within 2 hours prior to surgery

Secondary Outcome Measures

Name	Time	Method
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	within 2 hours prior to surgery

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada