Clinical trial NCT01326988: Real-time Ultrasound-guided Spinal Anesthesia:A Feasibility Study
Official title: Feasibility Study of the Use of Real-time Ultrasound Guidance to Administer Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Spinal Anesthesia
Keywords: Spinal anesthesia
ultrasound
real-time
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2011-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for elective lower limb orthopaedic surgery to a specialist orthopaedic hospital.

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.


Eligibility 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

Primary outcomes:
measure: Number of ventral passes of the spinal needle into the patient
timeFrame: Assessed at time of spinal anesthetic injection (baseline)
measure: Rate of successful performance of real-time ultrasound guided spinal needle insertion
timeFrame: Assessed at time of spinal anesthetic injection (baseline)
Secondary outcomes:
measure: Time for the procedure from first needle contact to the skin to injection of the medication into the spinal canal
timeFrame: Assessed at time of spinal anesthetic injection (baseline)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Orthopaedic & Arthritic Center
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Center
name: Paul McHardy, MD FRCPC BA
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Center
name: Patrick H Conroy, MB FFARCSI
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Center
name: Luyet Cedric, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Center
name: colin McCartney, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Furness G, Reilly MP, Kuchi S. An evaluation of ultrasound imaging for identification of lumbar intervertebral level. Anaesthesia. 2002 Mar;57(3):277-80. doi: 10.1046/j.1365-2044.2002.2403_4.x.
citation: Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
citation: Karmakar MK, Li X, Ho AM, Kwok WH, Chui PT. Real-time ultrasound-guided paramedian epidural access: evaluation of a novel in-plane technique. Br J Anaesth. 2009 Jun;102(6):845-54. doi: 10.1093/bja/aep079. Epub 2009 Apr 27.
citation: Tran D, Kamani AA, Al-Attas E, Lessoway VA, Massey S, Rohling RN. Single-operator real-time ultrasound-guidance to aim and insert a lumbar epidural needle. Can J Anaesth. 2010 Apr;57(4):313-21. doi: 10.1007/s12630-009-9252-1.
citation: Chin KJ, Chan VW, Ramlogan R, Perlas A. Real-time ultrasound-guided spinal anesthesia in patients with a challenging spinal anatomy: two case reports. Acta Anaesthesiol Scand. 2010 Feb;54(2):252-5. doi: 10.1111/j.1399-6576.2009.02112.x. Epub 2009 Oct 15.