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

Completed

• Conditions: Ultrasound Spinal Anesthesia
• Interventions: Procedure: Real-time ultrasound guided spinal anesthesia

• Registration Number: NCT01326988
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-03
• Last Update Posted: 2012-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients requiring spinal anesthesia for lower limb surgery	Real-time ultrasound guided spinal anesthesia	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time for the procedure from first needle contact to the skin to injection of the medication into the spinal canal	Assessed at time of spinal anesthetic injection (baseline)

Trial Locations

Locations (1)

Holland Orthopaedic & Arthritic Center; 🇨🇦 Toronto, Ontario, Canada