Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks

Spinal Anesthesia Clinical Trial

Official title:

A Randomised Controlled Trial of Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956137
• Other study ID #: 09-0190-AE
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: November 30, 2017
• Start date: May 2009
• Est. completion date: October 2010

Study information

• Verified date: January 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Procedure:
• Ultrasound guidance
ultrasound imaging
• Manual palpation
Manual Palpation of vertebra

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of dural puncture on the first needle insertion attempt.		within 2 hours prior to surgery
Secondary	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