Spinal AnesthesiaNCT01624844
Predictive Value of Ultrasound Measurement of the Dural Sac Volume on the Sensory Level in Spinal Anesthesia
A study testing Geometrical calculation of dural sac volume in people with Spinal Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The purpose of this study is to investigate whether the dural sac volume as determined by a geometrical calculation following multilevel measurements of its transverse area and length by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric bupivacaine in a non-obstetrical… 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?
- Geometrical calculation of dural sac volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Apr 2014
- 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
- Consenting patients aged 18-80 years
- ASA physical status 1-3
Who cannot join
- Contraindication to regional anesthesia (coagulopathy, sepsis or local infection at the site of injection, pre-existing neuropathy in the area involved)
- Surgery requiring the use of isobaric bupivacaine (0.5%)
- Allergy to local anesthetics (amide group)
- Anatomic abnormality of the spine (scoliosis, kyphosis)
- Previous spinal surgery
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
Official title: Predictive Value of an Ultrasound Model of Measurement of the Dural Sac Volume on the Sensory Level Obtained by Spinal Anesthesia
The purpose of this study is to investigate whether the dural sac volume as determined by a geometrical calculation following multilevel measurements of its transverse area and length by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric bupivacaine in a non-obstetrical population.
Read the detailed description
Sensory block extent may be difficult to predict in spinal anesthesia. Many factors influencing the intrathecal spread have been identified. Among the most important factors is the lumbosacral cerebrospinal fluid (CSF) volume and the dimensions of the dural sac. One study using magnetic resonance imaging (MRI) reported significant correlations between CSF volume and sensory block levels following spinal anesthesia. However, unlike ultrasound imaging, MRI can be difficult to obtain in the surgical setting. Although ultrasound imaging of the lumbar spine may not directly determine the CSF volume, multilevel measurements of the transverse area and length of the dural sac by ultrasound imaging followed by a geometrical calculation of its volume could help predict the extent of the intrathecal spread.
Methods: Patients scheduled for elective surgery under spinal anesthesia will be considered for this study. Ultrasound imaging will be achieved in a non-sterile manner with the patient in the sitting position. Spinal imaging will be performed using a low frequency probe. Focus and gain will be optimized. The first images will be made to identify the inter-laminar spaces from T11 to S1. At each level, the area of the dural sac will be measured in short axis using an adjustable ruler built-in the ultrasound monitor. The middle of the inter-laminar spaces will be marked on the patient's skin and the length of the dural sac will be defined as the distance between the middle of T11-12 and L5-S1. The total volume will be geometrically calculated. The L3-L4 space will be localized by triangulation and marked on the patient's skin as the optimal puncture site for spinal anesthesia. The optimal puncture angle will also be determined.
After placement of standard non-invasive monitoring, spinal anesthesia will be performed using 27-G Pencan needle. After aspiration of CSF, a solution of hyperbaric bupivacaine and fentanyl will be injected over a period of 15 seconds. The dose of bupivacaine will be determined by the attendant anaesthesiologist. The aspiration of CSF will be repeated at the end of the injection. Subsequently, the patient will be placed in supine position.
The extent of sensory block will be assessed by loss of pinprick sensation (using a #5.88 Von Frey filament) and loss of cold sensation to ice every 10 minutes until the same sensory level is observed in two consecutive assessments for a minimum period of 30 minutes. The extent of the block will be assessed bilaterally from caudal to cranial direction in the mid-clavicular line beginning at L3. The investigators will consider the peak sensory level as the uppermost blocked dermatome.
Total amount of crystalloids administered, incidence of significant hypotension and bradycardia will be recorded. Time to perform ultrasound measurements and time to discharge will also be noted. Resolution of the motor block will be assessed using the Bromage score at 3.5 hour, 4 and 4.5 hour following the injection of bupivacaine.
- Conditions
- Spinal Anesthesia
- Being tested
- Geometrical calculation of dural sac volume
- Keywords
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geometrical calculation of dural sac volumeOther
Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Calculation of dural sac volume | Experimental | Not described Receives: Other: Geometrical calculation of dural sac volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging
Measured: Before spinal anesthesia (Day 0)
Secondary outcomes (6)
Peak sensory level
Measured: From injection of bupivacaine until 30 minutes after injection (Day 0)
Time spent for ultrasound imaging measurements
Measured: Before spinal anesthesia (Day 0)
Duration of motor block
Measured: At 3.5, 4 and 4.5 hours following injection of bupivacaine (Day 0)
Incidence of side-effects related to spinal anesthesia
Measured: From spinal injection of bupivacaine until discharge from the hospital (Patients will be followed for the duration of hospital stay, an expected average of 3 days)
Length of stay in the recovery room
Measured: From arrival to discharge from the recovery room (Patients will be followed for the duration of stay in the recovery room on the day of surgery, an expected average of one hour)
Length of stay in the hospital
Measured: From surgery to discharge from the hospital (Patients will be followed for the duration of hospital stay, an expected average of 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionApr 2014
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 Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Garneau, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624844
- Sponsor's protocol ID
- SG 2012-001
- Status last verified
- Jun 2014
- First submitted
- 12 Jun 2012
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of an Ultrasound Model of Measurement of the Dural Sac Volume on the Sensory Level Obtained by Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01624844
- Acronym / sponsor ID
- SG 2012-001
- Conditions
- Spinal Anesthesia
- Keywords
- ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Jun 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.
The purpose of this study is to investigate whether the dural sac volume as determined by a geometrical calculation following multilevel measurements of its transverse area and length by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric bupivacaine in a non-obstetrical population.
Detailed description
Sensory block extent may be difficult to predict in spinal anesthesia. Many factors influencing the intrathecal spread have been identified. Among the most important factors is the lumbosacral cerebrospinal fluid (CSF) volume and the dimensions of the dural sac. One study using magnetic resonance imaging (MRI) reported significant correlations between CSF volume and sensory block levels following spinal anesthesia. However, unlike ultrasound imaging, MRI can be difficult to obtain in the surgical setting. Although ultrasound imaging of the lumbar spine may not directly determine the CSF volume, multilevel measurements of the transverse area and length of the dural sac by ultrasound imaging followed by a geometrical calculation of its volume could help predict the extent of the intrathecal spread.
Methods: Patients scheduled for elective surgery under spinal anesthesia will be considered for this study. Ultrasound imaging will be achieved in a non-sterile manner with the patient in the sitting position. Spinal imaging will be performed using a low frequency probe. Focus and gain will be optimized. The first images will be made to identify the inter-laminar spaces from T11 to S1. At each level, the area of the dural sac will be measured in short axis using an adjustable ruler built-in the ultrasound monitor. The middle of the inter-laminar spaces will be marked on the patient's skin and the length of the dural sac will be defined as the distance between the middle of T11-12 and L5-S1. The total volume will be geometrically calculated. The L3-L4 space will be localized by triangulation and marked on the patient's skin as the optimal puncture site for spinal anesthesia. The optimal puncture angle will also be determined.
After placement of standard non-invasive monitoring, spinal anesthesia will be performed using 27-G Pencan needle. After aspiration of CSF, a solution of hyperbaric bupivacaine and fentanyl will be injected over a period of 15 seconds. The dose of bupivacaine will be determined by the attendant anaesthesiologist. The aspiration of CSF will be repeated at the end of the injection. Subsequently, the patient will be placed in supine position.
The extent of sensory block will be assessed by loss of pinprick sensation (using a #5.88 Von Frey filament) and loss of cold sensation to ice every 10 minutes until the same sensory level is observed in two consecutive assessments for a minimum period of 30 minutes. The extent of the block will be assessed bilaterally from caudal to cranial direction in the mid-clavicular line beginning at L3. The investigators will consider the peak sensory level as the uppermost blocked dermatome.
Total amount of crystalloids administered, incidence of significant hypotension and bradycardia will be recorded. Time to perform ultrasound measurements and time to discharge will also be noted. Resolution of the motor block will be assessed using the Bromage score at 3.5 hour, 4 and 4.5 hour following the injection of bupivacaine.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calculation of dural sac volume | Experimental | Other: Geometrical calculation of dural sac volume |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consenting patients aged 18-80 years
- ASA physical status 1-3
Key exclusion criteria (6 listed)
- Contraindication to regional anesthesia (coagulopathy, sepsis or local infection at the site of injection, pre-existing neuropathy in the area involved)
- Surgery requiring the use of isobaric bupivacaine (0.5%)
- Allergy to local anesthetics (amide group)
- Anatomic abnormality of the spine (scoliosis, kyphosis)
- Previous spinal surgery
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 |
|---|---|---|
| Geometrical calculation of dural sac volumeGeometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging before spinal anesthesia | Other | Calculation of dural sac volume |
Primary outcome
Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging
Time frame: Before spinal anesthesia (Day 0)
6 secondary outcomes
Peak sensory level
Time frame: From injection of bupivacaine until 30 minutes after injection (Day 0)
Time spent for ultrasound imaging measurements
Time frame: Before spinal anesthesia (Day 0)
Duration of motor block
Time frame: At 3.5, 4 and 4.5 hours following injection of bupivacaine (Day 0)
Incidence of side-effects related to spinal anesthesia
Time frame: From spinal injection of bupivacaine until discharge from the hospital (Patients will be followed for the duration of hospital stay, an expected average of 3 days)
Length of stay in the recovery room
Time frame: From arrival to discharge from the recovery room (Patients will be followed for the duration of stay in the recovery room on the day of surgery, an expected average of one hour)
Length of stay in the hospital
Time frame: From surgery to discharge from the hospital (Patients will be followed for the duration of hospital stay, an expected average of 3 days)
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 9 Jun 2014.
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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.
Sébastien Garneau, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geometrical calculation of dural sac volume in people with Spinal Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 2 inclusion and 6 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 9 Jun 2014. 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?
Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging (time frame: Before spinal anesthesia (Day 0)). 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 9 Jun 2014.