Spinal AnesthesiaNCT00956137
Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks
A study testing Ultrasound guidance and Manual palpation in people with Spinal Anesthesia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Spinal anesthesia is the technique of choice in patients undergoing total joint arthroplasty at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of the lumbar vertebrae). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Ultrasound guidance and Manual palpation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Oct 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned spinal anesthesia for elective lower limb surgery; and one or more of the following:
- Body mass index ≥ 35 kgm-2
- Scoliosis or other spinal deformity
- Poorly palpable or impalpable spinous processes
Who cannot join
- Patient refusal
- Contra-indications to regional anesthesia
- Known allergy to local anesthetics
- Bleeding diathesis
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks.
Spinal anesthesia is the technique of choice in patients undergoing total joint arthroplasty at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of the lumbar vertebrae). These surface landmarks may be absent, indistinct or distorted in many of the patients presenting for total joint arthroplasty. This is because of obesity, previous spinal surgery, scoliosis and degenerative changes of aging. The investigators have shown in a previous study that a pre-procedural ultrasound scan of the spine can reliably identify an appropriate site for needle insertion in spinal anesthesia, and that this results in a high success rate on the first needle insertion attempt (84% vs 61-64% in published studies). The investigators therefore believe that this ultrasound-assisted technique of spinal anesthesia is extremely useful, especially in patients with poor-quality surface landmarks. However there are no published randomized controlled trials to date that compare the efficacy of the ultrasound-assisted technique with the traditional surface landmark-guided technique of spinal anesthesia.
- Conditions
- Spinal Anesthesia
- Being tested
- Ultrasound guidance, Manual palpation
- Keywords
- spinal anesthesia, ultrasound, palpation, knee, hip, surgery, intervertebral space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guidanceProcedure or surgery
ultrasound imaging
Manual palpationProcedure or surgery
Manual Palpation of vertebra
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Use of ultrasound to identify vertebral interspaces for needle insertion. Receives: Procedure: Ultrasound guidance |
| Palpation | Active comparator | Use of manual palpation to identify vertebral landmarks and vertebral interspaces for needle insertion. Receives: Procedure: Manual palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of dural puncture on the first needle insertion attempt.
Measured: within 2 hours prior to surgery
Secondary outcomes (1)
number of needle insertions/re-directions; performance time; Pain score; Patient satisfaction; quality of ultrasound image; Correlation between palpation and ultrasound; Correlation between ultrasound and measured depth to i.t. space
Measured: within 2 hours prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki Jinn Chin, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956137
- Sponsor's protocol ID
- 09-0190-AE
- Status last verified
- Jan 2010
- First submitted
- 17 Jul 2009
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Ultrasound-assisted Spinal Anaesthesia in Patients With Difficult Anatomical Landmarks.
- ClinicalTrials.gov ID
- NCT00956137
- Acronym / sponsor ID
- 09-0190-AE
- Conditions
- Spinal Anesthesia
- Keywords
- spinal anesthesia, ultrasound, palpation, knee, hip, surgery, intervertebral space
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Aug 2009 (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 is the technique of choice in patients undergoing total joint arthroplasty at Toronto Western Hospital (UHN). The most significant predictor of the ease of performance of spinal anesthesia is the quality of palpable surface landmarks (the spinous processes of the lumbar vertebrae). These surface landmarks may be absent, indistinct or distorted in many of the patients presenting for total joint arthroplasty. This is because of obesity, previous spinal surgery, scoliosis and degenerative changes of aging. The investigators have shown in a previous study that a pre-procedural ultrasound scan of the spine can reliably identify an appropriate site for needle insertion in spinal anesthesia, and that this results in a high success rate on the first needle insertion attempt (84% vs 61-64% in published studies). The investigators therefore believe that this ultrasound-assisted technique of spinal anesthesia is extremely useful, especially in patients with poor-quality surface landmarks. However there are no published randomized controlled trials to date that compare the efficacy of the ultrasound-assisted technique with the traditional surface landmark-guided technique of spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: Ultrasound guidanceUse of ultrasound to identify vertebral interspaces for needle insertion. |
| Palpation | Active comparator | Procedure: Manual palpationUse of manual palpation to identify vertebral landmarks and vertebral interspaces for needle insertion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned spinal anesthesia for elective lower limb surgery; and one or more of the following:
Key exclusion criteria (5 listed)
- Patient refusal
- Contra-indications to regional anesthesia
- Known allergy to local anesthetics
- Bleeding diathesis
- Inability to provide informed consent
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 guidanceultrasound imaging | Procedure or surgery | Ultrasound |
| Manual palpationManual Palpation of vertebra | Procedure or surgery | Palpation |
Primary outcome
The success rate of dural puncture on the first needle insertion attempt.
Time frame: within 2 hours prior to surgery
1 secondary outcome
number of needle insertions/re-directions; performance time; Pain score; Patient satisfaction; quality of ultrasound image; Correlation between palpation and ultrasound; Correlation between ultrasound and measured depth to i.t. space
Time frame: within 2 hours prior to surgery
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 4 Dec 2017.
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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.
Ki Jinn Chin, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guidance and Manual palpation in people with Spinal Anesthesia, run by University Health Network, Toronto 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 4 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 4 Dec 2017. 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?
The success rate of dural puncture on the first needle insertion attempt. (time frame: within 2 hours prior to surgery). 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 4 Dec 2017.