AnesthesiaNCT02658058
Pre-procedural Ultrasound Techniques Versus Conventional Landmark Technique of Spinal Anesthesia in Elderly Patients
A study testing Landmark technique, Ultrasound-guided paramedian technique and Ultrasound-guided midline technique in people with Anesthesia, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Traditionally, spinal anesthesia is performed using the palpation of bony landmark to identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has become an increasingly popular procedure among anesthesiologists to guide neuraxial blockade. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Landmark technique, Ultrasound-guided paramedian technique and Ultrasound-guided midline technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteLebanon
- Study dates
- Nov 2015to Jan 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for surgery amenable to spinal anesthesia, aged more than 60 years, with American Society of Anesthesiologists physical status 1 to 4.
Who cannot join
- Patients who are unable to give consent, refuse spinal anesthesia, have spinal abnormalities (including scoliosis and previous spine operations with instrumentation) or have contraindications to spinal anesthesia, including allergy to local anesthetics or a bleeding diathesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Pre-procedural Ultrasound Techniques Versus the Conventional Landmark Technique of Spinal Anesthesia in Elderly Patients
Traditionally, spinal anesthesia is performed using the palpation of bony landmark to identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has become an increasingly popular procedure among anesthesiologists to guide neuraxial blockade. Most of the studies on pre-procedural ultrasound-guided neuraxial techniques are limited to a midline approach using a transverse median views. The parasagittal oblique view consistently offers better ultrasound view of the neuraxis compared to the transverse median view. However, it is still not evident whether these superior parasagittal oblique views will lead to an easier paramedian needle insertion. In the literature, there are no studies directly comparing the US-guided paramedian approach using the parasagittal oblique (PSO) view, the US-guided midline approach using the transverse median view, and the conventional landmark midline approach to perform spinal anesthesia in the elderly patients, in particular for the teaching of novice anesthesia residents.
Read the detailed description
The aim of this study is to find out the optimal technique to perform spinal anesthesia by residents in training. Thus the investigators will compare preprocedural ultrasound-guided paramedian technique using parasagittal oblique view vs preprocedural ultrasound-guided midline technique using transverse median view vs landmark-guided midline technique of spinal anesthesia in the elderly population. Our hypothesis is that both preprocedural US-guided techniques are superior to the conventional landmark-guided midline technique with regard to ease of performance defined as success rate at first attempt, number of puncture attempts, spinal procedure time, and patient satisfaction.
- Conditions
- Anesthesia
- Being tested
- Landmark technique, Ultrasound-guided paramedian technique, Ultrasound-guided midline technique
- Keywords
- Ultrasound, Spinal anesthesia, Elderly, Landmark
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Landmark techniqueOther
The site of needle insertion will be determined via manual palpation. A line joining the superior aspect of the iliac crests posteriorly (Tuffier's line') will be used as a surface landmark for the L4 vertebral body. The midline will be established by palpation of the tips of the spinous processes, and the site of needle insertion will be marked on the patient's skin. The interspace that appears widest, based on manual palpation, will be chosen for the first attempt. If the first attempt is unsuccessful, further attempts can be made at the same interspace or another interspace.
Ultrasound-guided paramedian techniqueOther
The transducer will be applied in the parasagittal plane and the intervertebral levels will be identified by counting upwards from the sacrum (continuous hyperechoic line). The probe will then be angled obliquely to obtain a PSO view. The locations of the interlaminar spaces will be identified by visualizing the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body. The angulation at which the ligamentum flavum-dura mater complex and posterior vertebral body are best visualized will be considered the optimal angle for needle insertion and clearly communicated to the operator. The interlaminar space will be centered on the ultrasound screen and a skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe.
Ultrasound-guided midline techniqueOther
The transducer will be applied in the parasagittal plane, and after identification of the intervertebral levels, the probe will be rotated 90 degree to obtain the TM view. The transducer is moved in a cephalad-caudad direction between the spinous processes of L2 and L5 vertebra. The probe will be tilted slightly up and down to ensure a sufficient echogenic window at the selected intervertebral space. A skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe. The angle at which the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body are best visualized will be noted
| Study group | Role | What they receive |
|---|---|---|
| Landmark technique | Active comparator | As intervention, patients in this group are administered landmark guided midline spinal anesthesia. Receives: Other: Landmark technique |
| Ultrasound-guided paramedian technique | Experimental | As intervention, patients in this group are administered spinal anesthesia based on preprocedural ultrasound-guided paramedian technique using parasagittal oblique view Receives: Other: Ultrasound-guided paramedian technique |
| Ultrasound-guided midline technique | Experimental | As intervention, patients in this group are administered spinal anesthesia based on preprocedural ultrasound-guided midline technique using transverse median view Receives: Other: Ultrasound-guided midline technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful dural puncture on the first needle insertion attempt
Rate of successful dural puncture on the first needle insertion attempt which is defined as the percentage of successful dural puncture on the first introducer needle advancement through skin; each skin puncture by introducer is considered as a needle insertion attempt.
Measured: up to 5 minutes from the start of insertion of the introducer of the spinal needle
Secondary outcomes (5)
overall success rate in every technique
Overall success rate in every technique is defined as percentage of successful spinal anesthesia as evidenced by CSF flow through the spinal needle before spinal drug injection and a sensory block level >T10 15min after injection of spinal drug.
Measured: 60 minutes from the start of insertion of introducer of the spinal needle
Number of introducer needle insertion attempts
Number of introducer needle insertion attempts is defined as the number of times the introducer needle was withdrawn from the skin and reinserted.
Measured: 45 minutes from the start of insertion of introducer of the spinal needle
spinal procedure time
In groups US, period beginning when probe is first placed on patient's back and ending when examination is complete.
In group LM, period beginning when patient's back is palpated first and ending when examination is complete.
Measured: 60 minutes
patient satisfaction
Patient satisfaction will be scored as following:
- Very good
- Good
- Satisfactory
- Unpleasant
- Very unpleasant
Measured: 5 min after completion of administration of SA:
Number of spinal needle redirections
Spinal needle redirected without complete withdrawal of the introducer of the spinal needle from skin
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Sayyid, American University of Beirut Medical Center
- Investigators
- Sahar Siddik-Sayyid, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658058
- Sponsor's protocol ID
- ANES.SS.13
- Status last verified
- Jan 2019
- First submitted
- 11 Nov 2015
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rizk MS, Zeeni CA, Bouez JN, Bteich NJ, Sayyid SK, Alfahel WS, Siddik-Sayyid SM. Preprocedural ultrasound versus landmark techniques for spinal anesthesia performed by novice residents in elderly: a randomized controlled trial. BMC Anesthesiol. 2019 Nov 11;19(1):208. doi: 10.1186/s12871-019-0882-8.
PubMed 31711438
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Pre-procedural Ultrasound Techniques Versus the Conventional Landmark Technique of Spinal Anesthesia in Elderly Patients
- ClinicalTrials.gov ID
- NCT02658058
- Acronym / sponsor ID
- ANES.SS.13
- Conditions
- Anesthesia
- Keywords
- Ultrasound, Spinal anesthesia, Elderly, Landmark
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 18 Jan 2016 (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.
Traditionally, spinal anesthesia is performed using the palpation of bony landmark to identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has become an increasingly popular procedure among anesthesiologists to guide neuraxial blockade. Most of the studies on pre-procedural ultrasound-guided neuraxial techniques are limited to a midline approach using a transverse median views. The parasagittal oblique view consistently offers better ultrasound view of the neuraxis compared to the transverse median view. However, it is still not evident whether these superior parasagittal oblique views will lead to an easier paramedian needle insertion. In the literature, there are no studies directly comparing the US-guided paramedian approach using the parasagittal oblique (PSO) view, the US-guided midline approach using the transverse median view, and the conventional landmark midline approach to perform spinal anesthesia in the elderly patients, in particular for the teaching of novice anesthesia residents.
Detailed description
The aim of this study is to find out the optimal technique to perform spinal anesthesia by residents in training. Thus the investigators will compare preprocedural ultrasound-guided paramedian technique using parasagittal oblique view vs preprocedural ultrasound-guided midline technique using transverse median view vs landmark-guided midline technique of spinal anesthesia in the elderly population. Our hypothesis is that both preprocedural US-guided techniques are superior to the conventional landmark-guided midline technique with regard to ease of performance defined as success rate at first attempt, number of puncture attempts, spinal procedure time, and patient satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Landmark technique | Active comparator | Other: Landmark techniqueAs intervention, patients in this group are administered landmark guided midline spinal anesthesia. |
| Ultrasound-guided paramedian technique | Experimental | Other: Ultrasound-guided paramedian techniqueAs intervention, patients in this group are administered spinal anesthesia based on preprocedural ultrasound-guided paramedian technique using parasagittal oblique view |
| Ultrasound-guided midline technique | Experimental | Other: Ultrasound-guided midline techniqueAs intervention, patients in this group are administered spinal anesthesia based on preprocedural ultrasound-guided midline technique using transverse median view |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for surgery amenable to spinal anesthesia, aged more than 60 years, with American Society of Anesthesiologists physical status 1 to 4.
Key exclusion criteria (1 listed)
- Patients who are unable to give consent, refuse spinal anesthesia, have spinal abnormalities (including scoliosis and previous spine operations with instrumentation) or have contraindications to spinal anesthesia, including allergy to local anesthetics or a bleeding diathesis
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 |
|---|---|---|
| Landmark techniqueThe site of needle insertion will be determined via manual palpation. A line joining the superior aspect of the iliac crests posteriorly (Tuffier's line') will be used as a surface landmark for the L4 vertebral body. The midline will be established by palpation of the tips of the spinous processes, and the site of needle insertion will be marked on the patient's skin. The interspace that appears widest, based on manual palpation, will be chosen for the first attempt. If the first attempt is unsuccessful, further attempts can be made at the same interspace or another interspace. | Other | Landmark technique |
| Ultrasound-guided paramedian techniqueThe transducer will be applied in the parasagittal plane and the intervertebral levels will be identified by counting upwards from the sacrum (continuous hyperechoic line). The probe will then be angled obliquely to obtain a PSO view. The locations of the interlaminar spaces will be identified by visualizing the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body. The angulation at which the ligamentum flavum-dura mater complex and posterior vertebral body are best visualized will be considered the optimal angle for needle insertion and clearly communicated to the operator. The interlaminar space will be centered on the ultrasound screen and a skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe. | Other | Ultrasound-guided paramedian technique |
| Ultrasound-guided midline techniqueThe transducer will be applied in the parasagittal plane, and after identification of the intervertebral levels, the probe will be rotated 90 degree to obtain the TM view. The transducer is moved in a cephalad-caudad direction between the spinous processes of L2 and L5 vertebra. The probe will be tilted slightly up and down to ensure a sufficient echogenic window at the selected intervertebral space. A skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe. The angle at which the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body are best visualized will be noted | Other | Ultrasound-guided midline technique |
Primary outcome
Rate of successful dural puncture on the first needle insertion attempt
Time frame: up to 5 minutes from the start of insertion of the introducer of the spinal needle
Rate of successful dural puncture on the first needle insertion attempt which is defined as the percentage of successful dural puncture on the first introducer needle advancement through skin; each skin puncture by introducer is considered as a needle insertion attempt.
5 secondary outcomes
overall success rate in every technique
Time frame: 60 minutes from the start of insertion of introducer of the spinal needle
Number of introducer needle insertion attempts
Time frame: 45 minutes from the start of insertion of introducer of the spinal needle
spinal procedure time
Time frame: 60 minutes
patient satisfaction
Time frame: 5 min after completion of administration of SA:
Number of spinal needle redirections
Time frame: 45 minutes
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 10 Jan 2019.
- Derived from this study: PubMed 31711438Rizk MS, Zeeni CA, Bouez JN, Bteich NJ, Sayyid SK, Alfahel WS, Siddik-Sayyid SM. Preprocedural ultrasound versus landmark techniques for spinal anesthesia performed by novice residents in elderly: a randomized controlled trial. BMC Anesthesiol. 2019 Nov 11;19(1):208. doi: 10.1186/s12871-019-0882-8.
- Individual participant dataSharing planned: No
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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.
Sahar Siddik-Sayyid, 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 Landmark technique, Ultrasound-guided paramedian technique and Ultrasound-guided midline technique in people with Anesthesia, 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 1 inclusion and 1 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 10 Jan 2019. 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?
Rate of successful dural puncture on the first needle insertion attempt (time frame: up to 5 minutes from the start of insertion of the introducer of the spinal needle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658058, which also lists 1 linked publication.
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 10 Jan 2019.