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Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks

NCT ID: NCT00956137

Last Updated: 2017-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Spinal Anesthesia

Keywords

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spinal anesthesia ultrasound palpation knee hip surgery intervertebral space

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound

Use of ultrasound to identify vertebral interspaces for needle insertion.

Group Type EXPERIMENTAL

Ultrasound guidance

Intervention Type PROCEDURE

ultrasound imaging

Palpation

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

Group Type ACTIVE_COMPARATOR

Manual palpation

Intervention Type PROCEDURE

Manual Palpation of vertebra

Interventions

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Ultrasound guidance

ultrasound imaging

Intervention Type PROCEDURE

Manual palpation

Manual Palpation of vertebra

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ki Jinn Chin, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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09-0190-AE

Identifier Type: -

Identifier Source: org_study_id