Spinal Anesthesia AdministrationNCT01680913
Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients?
A study testing Ultrasound guidance, Palpation of Tuffier's line and Spinal anesthetic in people with Spinal Anesthesia Administration, run by University of Saskatchewan at 2 sites in Canada.
Trial summary
Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In obese patients, the commonly used landmarks may be difficult or even impossible to feel. In addition, the spine can be hidden beneath a layer of fatty tissue. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Anesthesia Administration
- What is being tested?
- Ultrasound guidance, Palpation of Tuffier's line and Spinal anesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2013to Dec 2013
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgeries amenable to spinal anesthetic
- BMI >35
- between the ages of 18-85
Who cannot join
- Patients with known spinal disease or previous spinal surgery
- Pregnant patients
- Patients requiring emergent surgeries
- Patients in positions other than sitting during neuroaxial anesthesia
- Patients with contraindications to neuroaxial anesthesia
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Saskatoon City Hospital
Saskatoon, Saskatchewan, S7K 0M7
Saint Paul's Hospital
Saskatoon, Saskatchewan, S7M 0Z9
About this study
Official title: Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients? A Randomized Controlled Study.
Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In obese patients, the commonly used landmarks may be difficult or even impossible to feel. In addition, the spine can be hidden beneath a layer of fatty tissue.
Ultrasound is useful for finding the correct injection site in pregnant patients, but the usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The potential benefits for obese patients from the use of ultrasound include shortening the duration of the procedure, increasing patient comfort, decreasing the total number of attempts, and aiding in the choice of appropriate needle length for the patient.
The investigators hypothesize that there is no difference in time to perform a spinal anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients with BMI > 35.
- Conditions
- Spinal Anesthesia Administration
- Being tested
- Ultrasound guidance, Palpation of Tuffier's line, Spinal anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guidanceProcedure or surgery
The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.
Palpation of Tuffier's lineProcedure or surgery
Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.
Spinal anestheticProcedure or surgery
Subcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist.
| Study group | Role | What they receive |
|---|---|---|
| Spinal with ultrasound guidance | Experimental | The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views. Receives: Procedure: Ultrasound guidance; Procedure: Spinal anesthetic |
| Spinal by palpation of Tuffier's line | Active comparator | Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal. Receives: Procedure: Palpation of Tuffier's line; Procedure: Spinal anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time to perform the spinal
Measured: From the beginning of palpation or ultrasound to free flow of Cerebral Spinal Fluid (CSF), up to 1 hour.
Secondary outcomes (4)
Time from administration of the local anesthetic needle until free flow CSF
Measured: Up to 1 hour
Number of needle redirections
Measured: At time of spinal anesthetic administration
Number of attempts to complete the spinal
As measured by new needle puncture sites, according to the anesthetist performing the procedure
Measured: At time of spinal anesthetic administration
Number of failed blocks
Defined as unable to get free flow CSF or inadequate surgical block after administration of neuraxial anesthetic after 15 minutes.
Measured: Up to 15 minutes after administration of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthesia AdministrationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacelyn Larson, University of Saskatchewan
- Investigators
- Jacelyn Larson, MD FRCP, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680913
- Sponsor's protocol ID
- U/S spinals
- Status last verified
- Nov 2016
- First submitted
- 28 Aug 2012
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients? A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT01680913
- Acronym / sponsor ID
- U/S spinals
- Conditions
- Spinal Anesthesia Administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Sep 2012 (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.
Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In obese patients, the commonly used landmarks may be difficult or even impossible to feel. In addition, the spine can be hidden beneath a layer of fatty tissue.
Ultrasound is useful for finding the correct injection site in pregnant patients, but the usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The potential benefits for obese patients from the use of ultrasound include shortening the duration of the procedure, increasing patient comfort, decreasing the total number of attempts, and aiding in the choice of appropriate needle length for the patient.
The investigators hypothesize that there is no difference in time to perform a spinal anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients with BMI > 35.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal with ultrasound guidance | Experimental | Procedure: Ultrasound guidance, Procedure: Spinal anestheticThe intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views. |
| Spinal by palpation of Tuffier's line | Active comparator | Procedure: Palpation of Tuffier's line, Procedure: Spinal anestheticCurrent clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing surgeries amenable to spinal anesthetic
- BMI >35
- between the ages of 18-85
Key exclusion criteria (5 listed)
- Patients with known spinal disease or previous spinal surgery
- Pregnant patients
- Patients requiring emergent surgeries
- Patients in positions other than sitting during neuroaxial anesthesia
- Patients with contraindications to neuroaxial anesthesia
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 |
|---|---|---|
| Ultrasound guidanceThe intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views. | Procedure or surgery | Spinal with ultrasound guidance |
| Palpation of Tuffier's lineCurrent clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal. | Procedure or surgery | Spinal by palpation of Tuffier's line |
| Spinal anestheticSubcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist. | Procedure or surgery | Spinal by palpation of Tuffier's line, Spinal with ultrasound guidance |
Primary outcome
Total time to perform the spinal
Time frame: From the beginning of palpation or ultrasound to free flow of Cerebral Spinal Fluid (CSF), up to 1 hour.
4 secondary outcomes
Time from administration of the local anesthetic needle until free flow CSF
Time frame: Up to 1 hour
Number of needle redirections
Time frame: At time of spinal anesthetic administration
Number of attempts to complete the spinal
Time frame: At time of spinal anesthetic administration
Number of failed blocks
Time frame: Up to 15 minutes after administration of spinal anesthesia
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 15 Nov 2016.
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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.
Jacelyn Larson, MD FRCP principal investigator
University of Saskatchewan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guidance, Palpation of Tuffier's line and Spinal anesthetic in people with Spinal Anesthesia Administration, run by University of Saskatchewan at 2 sites 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 3 inclusion and 5 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Total time to perform the spinal (time frame: From the beginning of palpation or ultrasound to free flow of Cerebral Spinal Fluid (CSF), up to 1 hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2016.