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

NCT ID: NCT01326988

Last Updated: 2012-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Ultrasound Spinal Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Real-time ultrasound guided spinal anesthesia

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul McHardy, MD FRCPC BA

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

Patrick H Conroy, MB FFARCSI

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

Luyet Cedric, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

colin McCartney, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

Locations

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Holland Orthopaedic & Arthritic Center

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 11892638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11172514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19398454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20196236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19839951 (View on PubMed)

Other Identifiers

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Real-time Spinal Ultrasound

Identifier Type: -

Identifier Source: org_study_id

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