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OpenTrials
Completed

NCT Number: NCT01326988

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Holland Orthopaedic & Arthritic Center

Toronto, Ontario, M4Y 1G4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time ultrasound guided spinal anesthesia

Procedure

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.

Primary outcomes

  1. Number of ventral passes of the spinal needle into the patient

    Time frame: Assessed at time of spinal anesthetic injection (baseline)

  2. Rate of successful performance of real-time ultrasound guided spinal needle insertion

    Time frame: Assessed at time of spinal anesthetic injection (baseline)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2011
Registry last updated
Feb 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.