Real-time Ultrasound-guided Spinal Anesthesia:A Feasibility Study

February 3, 2012 updated by: Sunnybrook Health Sciences Centre

Feasibility Study of the Use of Real-time Ultrasound Guidance to Administer Spinal Anesthesia

The traditional landmarks to locate the injection site and orientation of the spinal needle for spinal anesthesia are based on palpation of surface bony landmarks. However the actual injection target into the CSF is located at an unknown depth inside the patients 3 dimensional spinal anatomy which can itself vary in its orientation relative to these surface markers.Also bony surface markers may not be palpable in some patients or the patient may have altered spinal alignment. Thus an already blind procedure can become even more misguided involving multiple trial and error needle insertions. On the other hand ultrasound allows visualisation of deep target structures which are impalpable, it allows assessment of spinal alignment and thus directs the orientation of the seeking needle more accurately. Performing US in real-time during needle insertion gives continuous feedback about the correct needle approach path which should reduce the number of blind needle passes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4Y 1G4
        • Holland Orthopaedic & Arthritic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for elective lower limb orthopaedic surgery to a specialist orthopaedic hospital.

Description

Inclusion Criteria:

  • Consenting patients of at least 18 years of age undergoing spinal anesthesia for elective lower limb surgery

Exclusion Criteria (are as for Spinal anesthesia generally)

  • Patient refusal
  • Sepsis or local infection at the site of injection
  • Hypovolemia
  • Coagulopathy (INR ≥1.5, Platelets < 75X 109 /L, anticoagulant therapy)
  • Indeterminate neurologic disease
  • Increased intracranial pressure
  • Local anesthetic allergy
  • Infection distinct from the site of injection
  • Unknown duration of surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients requiring spinal anesthesia for lower limb surgery
Patients of at least 18 years of age undergoing spinal anesthesia for elective lower limb surgery will be recruited. Therefore inclusion and exclusion criteria are the same as for traditionally administered spinal anesthesia as below. Additionally we will exclude those patients who are incapable of providing fully informed consent, patients who are currently enrolled in other studies and patients with communication difficulties
Procedure: Real-time ultrasound guided spinal anesthesia
The neuraxial US scan will be performed with the patient in the sitting or lateral position with the hip and knees slightly flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance to administer the spinal anesthetic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of ventral passes of the spinal needle into the patient
Time Frame: Assessed at time of spinal anesthetic injection (baseline)
Assessed at time of spinal anesthetic injection (baseline)
Rate of successful performance of real-time ultrasound guided spinal needle insertion
Time Frame: Assessed at time of spinal anesthetic injection (baseline)
Assessed at time of spinal anesthetic injection (baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time for the procedure from first needle contact to the skin to injection of the medication into the spinal canal
Time Frame: Assessed at time of spinal anesthetic injection (baseline)
Assessed at time of spinal anesthetic injection (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Paul McHardy, MD FRCPC BA, Sunnybrook Health Sciences Center
  • Principal Investigator: Patrick H Conroy, MB FFARCSI, Sunnybrook Health Sciences Center
  • Principal Investigator: Luyet Cedric, MD, Sunnybrook Health Sciences Center
  • Principal Investigator: colin McCartney, FRCPC, Sunnybrook Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 30, 2011

First Posted (Estimate)

March 31, 2011

Study Record Updates

Last Update Posted (Estimate)

February 6, 2012

Last Update Submitted That Met QC Criteria

February 3, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Real-time Spinal Ultrasound

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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