PregnancyNCT01865955
Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia
A study testing Ultrasound and The spinal needle in people with Pregnancy, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Pre-procedural ultrasound for Spinal \& Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Ultrasound and The spinal needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Oct 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
- ASA physical status 1 - 3
- Written informed consent
- Gestational age ≥ 37 weeks.
Who cannot join
- Patient's refusal.
- Body mass index ≥ 45
- Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia in Term Parturients Undergoing Elective Caesarian Section- A Randomized Control Trial
Pre-procedural ultrasound for Spinal \& Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety.
The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population.
We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.
- Conditions
- Pregnancy
- Being tested
- Ultrasound, The spinal needle
- Keywords
- Ultrasound, Spinal anesthesia, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Ultrasound applied to the lumbar region to determine spinal needle placement.
The spinal needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Palpation | No intervention | Palpation will be used to determine placement of the spinal needle. |
| Ultrasound | Experimental | Ultrasound will be used prior to placement of the spinal needle. Receives: Procedure: Ultrasound; Device: The spinal needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal needle redirections
Number of redirections needed to perform a successful spinal puncture (presence of cerebrospinal fluid). A needle redirection is defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient's skin. The first needle pass will not be considered a redirection.
Measured: 15 minutes
Secondary outcomes (6)
Needle reinsertions
Number of needle reinsertions defined as complete withdrawal of the spinal needle to the patient's skin followed by a new attempt in the same interspace.
Measured: 15 minutes
Need to change to another interspace.
Relocating the spinal needle to another interspace.
Measured: 15 minutes
Procedure time
Time taken to perform the spinal anesthesia, measured from insertion of the introducer needle to visualization of spinal fluid.
Measured: 15 minutes
Pain score
Verbal Numerical Pain Scores during the procedure (0-10, where 0 means no pain and 10 mean the worst pain imaginable).
Measured: 15 minutes
Intervertebral level agreement
Intervertebral level agreement between L3-L4 obtained in the postoperative ultrasound assessment and the marked intervertebral level obtained pre-procedure, either by ultrasound or palpation.
Measured: 3 hours
Ultrasound Grading
Ultrasound Grading: The image pattern of the intervertebral space will be categorized into three grades by three study investigators not involved in providing the spinal anesthesia: Typical Image,Atypical Image or Inconclusive Image.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristian Arzola, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865955
- Sponsor's protocol ID
- 13-02
- Status last verified
- Jan 2014
- First submitted
- 28 May 2013
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia in Term Parturients Undergoing Elective Caesarian Section- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01865955
- Acronym / sponsor ID
- 13-02
- Conditions
- Pregnancy
- Keywords
- Ultrasound, Spinal anesthesia, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 31 May 2013 (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.
Pre-procedural ultrasound for Spinal \& Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety.
The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population.
We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation | No intervention | –Palpation will be used to determine placement of the spinal needle. |
| Ultrasound | Experimental | Procedure: Ultrasound, Device: The spinal needleUltrasound will be used prior to placement of the spinal needle. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
- ASA physical status 1 - 3
- Written informed consent
- Gestational age ≥ 37 weeks.
Key exclusion criteria (3 listed)
- Patient's refusal.
- Body mass index ≥ 45
- Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).
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 |
|---|---|---|
| UltrasoundUltrasound applied to the lumbar region to determine spinal needle placement. | Procedure or surgery | Ultrasound |
| The spinal needle | Device | Ultrasound |
Primary outcome
Spinal needle redirections
Time frame: 15 minutes
Number of redirections needed to perform a successful spinal puncture (presence of cerebrospinal fluid). A needle redirection is defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient's skin. The first needle pass will not be considered a redirection.
6 secondary outcomes
Needle reinsertions
Time frame: 15 minutes
Need to change to another interspace.
Time frame: 15 minutes
Procedure time
Time frame: 15 minutes
Pain score
Time frame: 15 minutes
Intervertebral level agreement
Time frame: 3 hours
Ultrasound Grading
Time frame: 3 hours
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 3 Feb 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.
Cristian Arzola, MD principal investigator
MOUNT SINAI HOSPITAL
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 and The spinal needle in people with Pregnancy, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital 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 3 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 3 Feb 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?
Spinal needle redirections (time frame: 15 minutes). 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 3 Feb 2014.