Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks

NCT00956137 | Completed

• 1 other identifier: 09-0190-AE
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia

Keywords

spinal anesthesia; ultrasound; palpation; knee; hip; surgery; intervertebral space

Outcome Measures

Primary Outcomes (1)

• The success rate of dural puncture on the first needle insertion attempt.

  within 2 hours prior to surgery

Secondary Outcomes (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

  within 2 hours prior to surgery

Study Arms (2)

Ultrasound

EXPERIMENTAL

Use of ultrasound to identify vertebral interspaces for needle insertion.

Procedure: Ultrasound guidance

Palpation

ACTIVE COMPARATOR

Use of manual palpation to identify vertebral landmarks and vertebral interspaces for needle insertion.

Procedure: Manual palpation

Interventions

Ultrasound guidance PROCEDURE

ultrasound imaging

Ultrasound

Manual palpation PROCEDURE

Manual Palpation of vertebra

Palpation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

• Ki Jinn Chin, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: August 11, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 4, 2017

Record last verified: 2010-01

Locations

CA (1)