Realtime UltrasoundNCT04214574
Real Time Ultrasound Guided Spinal Anesthesia in Elderly Patients
A study testing Parasagittal oblique technique (Ultrasound) and Paramedian tranverse technique (Ultrasound) in people with Realtime Ultrasound, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
In this prospective randomized observational study, investigators aim to compare the efficacy and procedural outcomes of real-time ultrasound guided parasagittal oblique (RTU-PO) and real-time ultrasound guided paramedian transverse (RTU-PT) approaches in elderly patients undergoing elective surgery under spinal… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Realtime Ultrasound
- What is being tested?
- Parasagittal oblique technique (Ultrasound) and Paramedian tranverse technique (Ultrasound)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteLebanon
- Study dates
- 30 Jan 2020to 4 Jul 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients aging above 65 years
- American Society of Anesthesiologists physical status 1 to 3
- Can give informed consent
- Scheduled for elective surgery
Who cannot join
- Inability to sit or to give consent
- Patients with severe cardiopulmonary diseases
- Previous back surgery or spinal congenital abnormalities
- Bleeding diathesis
- Anticoagulants or antiplatelets except aspirin
- Local anesthesia allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-Time Ultrasound-Guided Neuraxial Puncture in Elderly Patients: A Randomized Controlled Trial Comparing Between Paramedian Transverse and Parasagittal Oblique
In this prospective randomized observational study, investigators aim to compare the efficacy and procedural outcomes of real-time ultrasound guided parasagittal oblique (RTU-PO) and real-time ultrasound guided paramedian transverse (RTU-PT) approaches in elderly patients undergoing elective surgery under spinal anesthesia.
Read the detailed description
Background: Since its first introduction in 1898 by Bier, Spinal anesthesia has been performed using the anatomical landmark guided approach. Despite being useful, the landmark technique doesn't take into account anatomical variations, spine abnormalities or age-related changes in the lumbar spine as seen in elderly, obese or pregnant patients and thus can lead to incorrect identification of a certain interspace. Neuraxial ultrasonography has been introduced as a technique to allow the operator to preview spinal anatomy, identify the midline, determine the interspace and guide the needle insertion site and trajectory. It was found to be a feasible and promising technique that can result in successful cerebrospinal fluid acquisition where other methods have failed. While pre-procedural Ultrasound has been used by many studies to identify the right epidural or subarachnoid spaces and have an idea about the angle of needle insertion, it remains a blind technique. Real-time ultrasound guided technique was found to improve the limitations of the pre-puncture ultrasound guided techniques by direct, real-time visualization of the needle trajectory. In spinal anesthesia, a midline approach has been the most common technique used for needle insertion. However, this approach is often technically difficult in the geriatric population because of poorly palpable surface landmarks, lumbar scoliosis, marked thoracic kyphosis, degenerative changes and inability to flex the lumbar spine in the sitting position. While the parasagittal oblique approach tends to provide a better sonographic window into the vertebral canal than the midline approach, it is still not evident whether it will lead to an easier paramedian needle insertion. In the literature, there are no studies directly comparing the paramedian transverse and parasagittal oblique approaches in the performance of real time ultrasound guided spinal anesthesia.
Specific Aim: The aim of this study is to find out the optimal approach to perform spinal anesthesia under real time ultrasound guidance in the elderly population. Thus, investigators will compare real time ultrasound-guided paramedian approach using parasagittal oblique view with real time ultrasound guided paramedian approach using the paramedian transverse median view. The aim is thus to adopt a real time ultrasound guided technique that will result in an easier access to the subarachnoid space in patients with difficult anatomy and results in better patient satisfaction and less discomfort.
Methodology and analysis: In a prospective randomized observational study, 84 patients scheduled for surgery amenable to spinal anesthesia, aged more than 65 years, with American Society of Anesthesiologists physical status 1 to 3 will be assigned to receive spinal anesthesia to one of two treatment groups: real time ultrasound-guided parasagittal oblique technique (group RTU-PO) or Real time ultrasound-guided paramedian transverse technique (group RTU-T). Ultrasonography of the lumbar spine and Real time spinal blockade will be performed by the experienced anesthesiologist. Patients in both groups will have an ultrasound scan of the lumbar spine to measure the depth of the dura, to specify and guide the needle insertion site and trajectory. The primary outcome is the rate of successful dural puncture on the first needle insertion attempt under real time ultrasound guidance. Normally distributed data will be summarized as mean ± SD and nonnormally distributed data will be summarized as median [interquartile range].
Significance: Investigators believe that real time US-guided technique is a superior modality of performance of spinal anesthesia. However, investigators would like to evaluate which approach will be better for the acquisition of cerebrospinal fluid in elderly patients. Investigators think that this study would have an impact on current practice in term of introducing real time ultrasound guided technique into everyday practice and determining the best approach to perform a successful neuraxial block in a patient with a suspected difficult back.
- Conditions
- Realtime Ultrasound
- Being tested
- Parasagittal oblique technique (Ultrasound), Paramedian tranverse technique (Ultrasound)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasagittal oblique technique (Ultrasound)Device
the probe will be placed in a parasagittal plane to identify the articular processes then the sacrum will be identified. The probe will be moved cephalad in the parasagittal axis until the identification of the target lumbar interspaces L2-L3, L3-L4 or L4-L5. Once the appropriate lumbar interspace is identified, the probe will be tilted 45 degree towards the midline into a parasagittal oblique view. The needle will be inserted in plane from the caudal end of the ultrasound transducer with its tip directed towards the interlaminar space under real-time in-plane US guidance.
Paramedian tranverse technique (Ultrasound)Device
the transducer will be applied in the parasagittal plane, and after identification of the intervertebral level, the probe will be rotated 90 degrees into a transverse orientation and centered on the neuraxial midline in a way to align the beam with the interspinous and interlaminar space and thus to get a paramedian transverse interlaminar view. The needle will be inserted in plane from the lateral end of the ultrasound transducer with its tip directed towards the medial border of the articular process.
| Study group | Role | What they receive |
|---|---|---|
| Real time ultrasound-guided Parasagittal oblique technique (RTU-PO) | Experimental | In the RTU-PO group, the probe will be placed in a parasagittal plane to identify the articular processes then the sacrum will be identified. The probe will be moved cephalad in the parasagittal axis until the identification of the target lumbar interspaces L2-L3, L3-L4 or L4-L5. Once the appropriate lumbar interspace is identified, the probe will be tilted 45 degree towards the midline into a parasagittal oblique view. This provides a view of the paramedian interlaminar space. The ligamentum flavum and the dura form the posterior complex that can be often visualized as a single hyperechoic structure beneath which lies the hypoechoic intrathecal space. The needle will be inserted in plane from the caudal end of the ultrasound transducer with its tip directed towards the interlaminar space under real-time in-plane US guidance. Receives: Device: Parasagittal oblique technique (Ultrasound) |
| Real time ultrasound-guided paramedian tranverse technique (RTU-T) | Experimental | In the RTU-T group, similar to the RTU-PO group, the transducer will be applied in the parasagittal plane, and after identification of the intervertebral level, the probe will be rotated 90 degrees into a transverse orientation and centered on the neuraxial midline in a way to align the beam with the interspinous and interlaminar space and thus to get a paramedian transverse interlaminar view. The needle will be inserted in plane from the lateral end of the ultrasound transducer with its tip directed towards the medial border of the articular process. Receives: Device: Paramedian tranverse technique (Ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of successful Dural puncture on the first needle insertion attempt
Successful needle insertion on the first attempt (Yes/No)
Measured: At the begining of the procedure (during the needle insertion)
Secondary outcomes (12)
Incidence of success of spinal anesthesia
Success of spinal anesthesia (Yes/No)
Measured: During the procedure
Time to identify posterior complex on ultrasound
Time to identify posterior complex on ultrasound (measured in seconds)
Measured: During the procedure
Time to perform spinal anesthesia
Time to perform spinal anesthesia (measured in seconds)
Measured: During the procedure
Procedural time
Procedural time (measured in minutes)
Measured: During the procedure
Depth of the posterior complex
Depth of the posterior complex (measured in cm)
Measured: During the procedure
Number of redirections
Number of redirections
Measured: During the procedure
Number of needle passes
Number of needle passes
Measured: During the procedure
Number of separate skin punctures
Number of separate skin punctures
Measured: During the procedure
Number of spinal levels attempted
Number of spinal levels attempted
Measured: During the procedure
Rate of satisfaction
Patient satisfaction (scale from 1 to 3: very satisfied, satisfied, dissatisfied)
Measured: After the procedure
Rate of complications
Complications (Yes/No)
Measured: During the procedure
Rate of complications, if present
Complications if present (Vascular puncture, Paresthesia, Conversion to GA 30 minutes after block, and Others)
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start30 Jan 2020
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Realtime UltrasoundStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Rizk, American University of Beirut Medical Center
- Investigators
- Marwan Rizk, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214574
- Sponsor's protocol ID
- BIO-2018-0589
- Status last verified
- Jul 2024
- First submitted
- 28 Dec 2019
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Ultrasound-Guided Neuraxial Puncture in Elderly Patients: A Randomized Controlled Trial Comparing Between Paramedian Transverse and Parasagittal Oblique
- ClinicalTrials.gov ID
- NCT04214574
- Acronym / sponsor ID
- BIO-2018-0589
- Conditions
- Realtime Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 2 Jan 2020 (actual)
- 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.
In this prospective randomized observational study, investigators aim to compare the efficacy and procedural outcomes of real-time ultrasound guided parasagittal oblique (RTU-PO) and real-time ultrasound guided paramedian transverse (RTU-PT) approaches in elderly patients undergoing elective surgery under spinal anesthesia.
Detailed description
Background: Since its first introduction in 1898 by Bier, Spinal anesthesia has been performed using the anatomical landmark guided approach. Despite being useful, the landmark technique doesn't take into account anatomical variations, spine abnormalities or age-related changes in the lumbar spine as seen in elderly, obese or pregnant patients and thus can lead to incorrect identification of a certain interspace. Neuraxial ultrasonography has been introduced as a technique to allow the operator to preview spinal anatomy, identify the midline, determine the interspace and guide the needle insertion site and trajectory. It was found to be a feasible and promising technique that can result in successful cerebrospinal fluid acquisition where other methods have failed. While pre-procedural Ultrasound has been used by many studies to identify the right epidural or subarachnoid spaces and have an idea about the angle of needle insertion, it remains a blind technique. Real-time ultrasound guided technique was found to improve the limitations of the pre-puncture ultrasound guided techniques by direct, real-time visualization of the needle trajectory. In spinal anesthesia, a midline approach has been the most common technique used for needle insertion. However, this approach is often technically difficult in the geriatric population because of poorly palpable surface landmarks, lumbar scoliosis, marked thoracic kyphosis, degenerative changes and inability to flex the lumbar spine in the sitting position. While the parasagittal oblique approach tends to provide a better sonographic window into the vertebral canal than the midline approach, it is still not evident whether it will lead to an easier paramedian needle insertion. In the literature, there are no studies directly comparing the paramedian transverse and parasagittal oblique approaches in the performance of real time ultrasound guided spinal anesthesia.
Specific Aim: The aim of this study is to find out the optimal approach to perform spinal anesthesia under real time ultrasound guidance in the elderly population. Thus, investigators will compare real time ultrasound-guided paramedian approach using parasagittal oblique view with real time ultrasound guided paramedian approach using the paramedian transverse median view. The aim is thus to adopt a real time ultrasound guided technique that will result in an easier access to the subarachnoid space in patients with difficult anatomy and results in better patient satisfaction and less discomfort.
Methodology and analysis: In a prospective randomized observational study, 84 patients scheduled for surgery amenable to spinal anesthesia, aged more than 65 years, with American Society of Anesthesiologists physical status 1 to 3 will be assigned to receive spinal anesthesia to one of two treatment groups: real time ultrasound-guided parasagittal oblique technique (group RTU-PO) or Real time ultrasound-guided paramedian transverse technique (group RTU-T). Ultrasonography of the lumbar spine and Real time spinal blockade will be performed by the experienced anesthesiologist. Patients in both groups will have an ultrasound scan of the lumbar spine to measure the depth of the dura, to specify and guide the needle insertion site and trajectory. The primary outcome is the rate of successful dural puncture on the first needle insertion attempt under real time ultrasound guidance. Normally distributed data will be summarized as mean ± SD and nonnormally distributed data will be summarized as median [interquartile range].
Significance: Investigators believe that real time US-guided technique is a superior modality of performance of spinal anesthesia. However, investigators would like to evaluate which approach will be better for the acquisition of cerebrospinal fluid in elderly patients. Investigators think that this study would have an impact on current practice in term of introducing real time ultrasound guided technique into everyday practice and determining the best approach to perform a successful neuraxial block in a patient with a suspected difficult back.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real time ultrasound-guided Parasagittal oblique technique (RTU-PO) | Experimental | Device: Parasagittal oblique technique (Ultrasound)In the RTU-PO group, the probe will be placed in a parasagittal plane to identify the articular processes then the sacrum will be identified. The probe will be moved cephalad in the parasagittal axis until the identification of the target lumbar interspaces L2-L3, L3-L4 or L4-L5. Once the appropriate lumbar interspace is identified, the probe will be tilted 45 degree towards the midline into a parasagittal oblique view. This provides a view of the paramedian interlaminar space. The ligamentum flavum and the dura form the posterior complex that can be often visualized as a single hyperechoic structure beneath which lies the hypoechoic intrathecal space. The needle will be inserted in plane from the caudal end of the ultrasound transducer with its tip directed towards the interlaminar space under real-time in-plane US guidance. |
| Real time ultrasound-guided paramedian tranverse technique (RTU-T) | Experimental | Device: Paramedian tranverse technique (Ultrasound)In the RTU-T group, similar to the RTU-PO group, the transducer will be applied in the parasagittal plane, and after identification of the intervertebral level, the probe will be rotated 90 degrees into a transverse orientation and centered on the neuraxial midline in a way to align the beam with the interspinous and interlaminar space and thus to get a paramedian transverse interlaminar view. The needle will be inserted in plane from the lateral end of the ultrasound transducer with its tip directed towards the medial border of the articular process. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aging above 65 years
- American Society of Anesthesiologists physical status 1 to 3
- Can give informed consent
- Scheduled for elective surgery
Key exclusion criteria (6 listed)
- Inability to sit or to give consent
- Patients with severe cardiopulmonary diseases
- Previous back surgery or spinal congenital abnormalities
- Bleeding diathesis
- Anticoagulants or antiplatelets except aspirin
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 |
|---|---|---|
| Parasagittal oblique technique (Ultrasound)the probe will be placed in a parasagittal plane to identify the articular processes then the sacrum will be identified. The probe will be moved cephalad in the parasagittal axis until the identification of the target lumbar interspaces L2-L3, L3-L4 or L4-L5. Once the appropriate lumbar interspace is identified, the probe will be tilted 45 degree towards the midline into a parasagittal oblique view. The needle will be inserted in plane from the caudal end of the ultrasound transducer with its tip directed towards the interlaminar space under real-time in-plane US guidance. | Device | Real time ultrasound-guided Parasagittal oblique technique (RTU-PO) |
| Paramedian tranverse technique (Ultrasound)the transducer will be applied in the parasagittal plane, and after identification of the intervertebral level, the probe will be rotated 90 degrees into a transverse orientation and centered on the neuraxial midline in a way to align the beam with the interspinous and interlaminar space and thus to get a paramedian transverse interlaminar view. The needle will be inserted in plane from the lateral end of the ultrasound transducer with its tip directed towards the medial border of the articular process. | Device | Real time ultrasound-guided paramedian tranverse technique (RTU-T) |
Primary outcome
Incidence of successful Dural puncture on the first needle insertion attempt
Time frame: At the begining of the procedure (during the needle insertion)
Successful needle insertion on the first attempt (Yes/No)
12 secondary outcomes
Incidence of success of spinal anesthesia
Time frame: During the procedure
Time to identify posterior complex on ultrasound
Time frame: During the procedure
Time to perform spinal anesthesia
Time frame: During the procedure
Procedural time
Time frame: During the procedure
Depth of the posterior complex
Time frame: During the procedure
Number of redirections
Time frame: During the procedure
Number of needle passes
Time frame: During the procedure
Number of separate skin punctures
Time frame: During the procedure
Number of spinal levels attempted
Time frame: During the procedure
Rate of satisfaction
Time frame: After the procedure
Rate of complications
Time frame: During the procedure
Rate of complications, if present
Time frame: During the procedure
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 25 Jul 2024.
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.
Marwan Rizk, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasagittal oblique technique (Ultrasound) and Paramedian tranverse technique (Ultrasound) in people with Realtime Ultrasound, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 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 25 Jul 2024. 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 Lebanon. 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?
Incidence of successful Dural puncture on the first needle insertion attempt (time frame: At the begining of the procedure (during the needle insertion)). 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 25 Jul 2024.