Ultrasound Spinal AnesthesiaNCT01326988
Real-time Ultrasound-guided Spinal Anesthesia:A Feasibility Study
An observational study of Ultrasound Spinal Anesthesia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound Spinal Anesthesia
- What is being tested?
- Real-time ultrasound guided spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for elective lower limb orthopaedic surgery to a specialist orthopaedic hospital.
Who may be able to join
- Consenting patients of at least 18 years of age undergoing spinal anesthesia for elective lower limb surgery
Who cannot join
- 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
Show all 9Show fewer
- Local anesthetic allergy
- Infection distinct from the site of injection
- Unknown duration of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the Use of Real-time Ultrasound Guidance to Administer Spinal Anesthesia
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.
- Conditions
- Ultrasound Spinal Anesthesia
- Being tested
- Real-time ultrasound guided spinal anesthesia
- Keywords
- Spinal anesthesia, ultrasound, real-time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time ultrasound guided spinal anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Real-time ultrasound guided spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventral passes of the spinal needle into the patient
Measured: Assessed at time of spinal anesthetic injection (baseline)
Rate of successful performance of real-time ultrasound guided spinal needle insertion
Measured: 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
Measured: Assessed at time of spinal anesthetic injection (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul McHardy, MD FRCPC BA, Principal investigator, Sunnybrook Health Sciences CentrePatrick H Conroy, MB FFARCSI, Principal investigator, Sunnybrook Health Sciences CentreLuyet Cedric, MD, Principal investigator, Sunnybrook Health Sciences Centrecolin McCartney, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326988
- Sponsor's protocol ID
- Real-time Spinal Ultrasound
- Status last verified
- Feb 2012
- First submitted
- 23 Mar 2011
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11892638Grau 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.
PubMed 11172514Karmakar 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.
PubMed 19398454Tran 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.
PubMed 20196236Chin 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.
PubMed 19839951
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Use of Real-time Ultrasound Guidance to Administer Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01326988
- Acronym / sponsor ID
- Real-time Spinal Ultrasound
- Conditions
- Ultrasound Spinal Anesthesia
- Keywords
- Spinal anesthesia, ultrasound, real-time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring spinal anesthesia for lower limb surgery | – | Procedure: Real-time ultrasound guided spinal anesthesiaPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for elective lower limb orthopaedic surgery to a specialist orthopaedic hospital.
Key inclusion criteria (1 listed)
- Consenting patients of at least 18 years of age undergoing spinal anesthesia for elective lower limb surgery
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time ultrasound guided spinal anesthesiaThe 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. | Procedure or surgery | Patients requiring spinal anesthesia for lower limb surgery |
Primary outcome
Number of ventral passes of the spinal needle into the patient
Time frame: Assessed at time of spinal anesthetic injection (baseline)
Rate of successful performance of real-time ultrasound guided spinal needle insertion
Time frame: Assessed at time of spinal anesthetic injection (baseline)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2012.
- Background: PubMed 11892638Furness 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.
- Background: PubMed 11172514Grau 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.
- Background: PubMed 19398454Karmakar 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.
- Background: PubMed 20196236Tran 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.
- Background: PubMed 19839951Chin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul McHardy, MD FRCPC BA principal investigator
Sunnybrook Health Sciences Centre
Patrick H Conroy, MB FFARCSI principal investigator
Sunnybrook Health Sciences Centre
Luyet Cedric, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Spinal Anesthesia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ventral passes of the spinal needle into the patient (time frame: Assessed at time of spinal anesthetic injection (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01326988, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2012.