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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01326988
First received: March 23, 2011
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Ultrasound Spinal Anesthesia
Procedure: Real-time ultrasound guided spinal anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Study of the Use of Real-time Ultrasound Guidance to Administer Spinal Anesthesia

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Number of ventral passes of the spinal needle into the patient [ Time Frame: Assessed at time of spinal anesthetic injection (baseline) ] [ Designated as safety issue: Yes ]
  • Rate of successful performance of real-time ultrasound guided spinal needle insertion [ Time Frame: Assessed at time of spinal anesthetic injection (baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326988

Locations
Canada, Ontario
Holland Orthopaedic & Arthritic Center
Toronto, Ontario, Canada, M4Y 1G4
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01326988     History of Changes
Other Study ID Numbers: Real-time Spinal Ultrasound
Study First Received: March 23, 2011
Last Updated: February 3, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Spinal anesthesia
ultrasound
real-time

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014