AnaesthesiaNCT02171975
Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia
A study testing pre-procedure ultrasound guided paramedian spinal and Conventional landmark guided midline spinal anaesthetic in people with Anaesthesia, run by Cork University Hospital at 1 site in Ireland.
Trial summary
Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The investigators hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinals reduces the number of passes required… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- pre-procedure ultrasound guided paramedian spinal and Conventional landmark guided midline spinal anaesthetic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2014to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consented patients scheduled to undergo elective total knee or total hip arthroplasty under spinal anesthesia were included in the study.
Who cannot join
- Patients with contraindications to spinal anesthesia (allergy to local anesthetic, coagulopathy, local infection and indeterminate neurological disease) were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Conventional Landmark Guided Midline Versus Pre-procedure Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia
Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The investigators hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinals reduces the number of passes required to achieve enter the subarachnoid space when compared to the conventional landmark-guided midline approach.
Read the detailed description
Spinal anesthesia is widely performed using a surface landmark based 'blind' technique. Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma.
Real time and pre-procedural neuraxial ultrasound techniques have been used to improve the success rate of spinal anesthesia. The use of real time ultrasound-guided spinal anesthesia has to date been limited to case series and case reports. Its use may be limited by the requirement for wide bore needles and the technical difficulties associated with simultaneous ultrasound scanning and needle advancement. The use of pre-procedural ultrasound has been shown to increase the first pass success rate for spinal anesthesia only in patients with difficult surface anatomic landmarks.No technique has been shown to improve the success rate of dural puncture when applied routinely to all patients.
Studies on pre-procedural ultrasound-guided spinal techniques are limited to a midline approach using a transverse median view (TM). The parasagittal oblique (PSO) view consistently offers better ultrasound view of the neuraxis compared to TM views. However no studies have been conducted to assess whether these superior PSO views translate into easier paramedian needle insertion.
We hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinal technique results in less number of passes required to enter the subarachnoid space when compared to the conventional landmark based midline approach.
- Conditions
- Anaesthesia
- Being tested
- pre-procedure ultrasound guided paramedian spinal, Conventional landmark guided midline spinal anaesthetic
- Keywords
- Spinal anaesthesia, Ultrasound pre-procedure guided, Paramedian spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-procedure ultrasound guided paramedian spinalProcedure or surgery
In group P, a portable ultrasound unit was used for initial pre-procedural marking. The interspinous space at which the clearest image of the anterior complex (ligamentum flavum dura complex- LFD) and posterior complex (posterior longitudinal ligament- PLL) was obtained, was selected. At the selected interspace, and with the probe positioned to obtain the clearest ultrasound image, a skin marker was used to mark the midpoint of the long border of the probe and the midpoints of the short borders of the probe . At the same horizontal level as the midpoint of the long border of the probe, the midpoint of the line drawn between the two short border midpoints of the probe was used as paramedian insertion point for the spinal needle.
Conventional landmark guided midline spinal anaestheticProcedure or surgery
Spinal anaesthesia was administered based on conventional landmark based midline approach.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Patients in this group underwent Conventional landmark guided midline spinal anaesthetic. Receives: Procedure: Conventional landmark guided midline spinal anaesthetic |
| Group P | Experimental | This group had their spinal anaesthetic done based on pre-procedure ultrasound guided paramedian spinal Receives: Procedure: pre-procedure ultrasound guided paramedian spinal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of passes
The number of passes, defined as the number of forward advancements of the spinal needle in a given interspinous space (i.e. withdrawal and redirection of spinal needle without exiting the skin)
Measured: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Secondary outcomes (10)
Number of spinal needle insertion attempts
number of spinal needle insertion attempts (defined as the number of times the spinal needle was withdrawn from the skin and reinserted) were noted
Measured: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Blood in spinal needle
Presence of blood in spinal needle
Measured: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Time for identifying landmarks
Time for identifying landmarks in group C was defined as time from which the anesthesiologist started palpating to identify the landmarks to completion of the process as declared by the anesthesiologist. In group P it was defined as time from which the ultrasound probe was placed on the skin to the anesthesiologist declaring that the markings are completed
Measured: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete
Time taken for performing spinal anesthetic
defined as time taken from insertion of introducer needle to completion of injection
Measured: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Incidence of radicular pain
Shooting pain going down along one of the dermatomal levels in the leg
Measured: Up to 24 hours after administration of spinal anaesthetic
Presence of paresthesia
Paresthesia along dermatomal distribution during performing spinal anaesthetic
Measured: Up to 24 hours after administration of spinal anaesthetic
Grading of palpated landmarks
Anesthesiologist palpated the landmarks after positioning and graded the ease of palpation on a 4 point scale (easy, moderate, difficult or impossible)
Measured: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete
Peri-procedural VAS scores of pain at injection site
After positioning and prior to administration of sedation, patients were asked for their peri-procedural pain scores measured using an 11 point verbal rating scale (0=no pain, 10=most pain imaginable)
Measured: up to 30 minutes following spinal anaesthetic injection and prior to sedation
peri-procedural discomfort scores
peri-procedural discomfort scores measured using an 11 point verbal rating measured (0= no discomfort, 10=most discomfort imaginable).
Measured: up to 30 minutes following spinal anaesthetic injection and prior to sedation
Level of block
Dermatomal level at which loss of cold sensation (ethyl chloride spray) occurs
Measured: 15 minutes after spinal anaesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital
- Investigators
- Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD, Principal investigator, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171975
- Sponsor's protocol ID
- ECM 4(j) 04/02/14
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Conventional Landmark Guided Midline Versus Pre-procedure Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02171975
- Acronym / sponsor ID
- ECM 4(j) 04/02/14
- Conditions
- Anaesthesia
- Keywords
- Spinal anaesthesia, Ultrasound pre-procedure guided, Paramedian spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Jun 2014 (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.
Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The investigators hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinals reduces the number of passes required to achieve enter the subarachnoid space when compared to the conventional landmark-guided midline approach.
Detailed description
Spinal anesthesia is widely performed using a surface landmark based 'blind' technique. Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma.
Real time and pre-procedural neuraxial ultrasound techniques have been used to improve the success rate of spinal anesthesia. The use of real time ultrasound-guided spinal anesthesia has to date been limited to case series and case reports. Its use may be limited by the requirement for wide bore needles and the technical difficulties associated with simultaneous ultrasound scanning and needle advancement. The use of pre-procedural ultrasound has been shown to increase the first pass success rate for spinal anesthesia only in patients with difficult surface anatomic landmarks.No technique has been shown to improve the success rate of dural puncture when applied routinely to all patients.
Studies on pre-procedural ultrasound-guided spinal techniques are limited to a midline approach using a transverse median view (TM). The parasagittal oblique (PSO) view consistently offers better ultrasound view of the neuraxis compared to TM views. However no studies have been conducted to assess whether these superior PSO views translate into easier paramedian needle insertion.
We hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinal technique results in less number of passes required to enter the subarachnoid space when compared to the conventional landmark based midline approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Procedure: Conventional landmark guided midline spinal anaestheticPatients in this group underwent Conventional landmark guided midline spinal anaesthetic. |
| Group P | Experimental | Procedure: pre-procedure ultrasound guided paramedian spinalThis group had their spinal anaesthetic done based on pre-procedure ultrasound guided paramedian spinal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consented patients scheduled to undergo elective total knee or total hip arthroplasty under spinal anesthesia were included in the study.
Key exclusion criteria (1 listed)
- Patients with contraindications to spinal anesthesia (allergy to local anesthetic, coagulopathy, local infection and indeterminate neurological disease) were excluded from the study.
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 |
|---|---|---|
| pre-procedure ultrasound guided paramedian spinalIn group P, a portable ultrasound unit was used for initial pre-procedural marking. The interspinous space at which the clearest image of the anterior complex (ligamentum flavum dura complex- LFD) and posterior complex (posterior longitudinal ligament- PLL) was obtained, was selected. At the selected interspace, and with the probe positioned to obtain the clearest ultrasound image, a skin marker was used to mark the midpoint of the long border of the probe and the midpoints of the short borders of the probe . At the same horizontal level as the midpoint of the long border of the probe, the midpoint of the line drawn between the two short border midpoints of the probe was used as paramedian insertion point for the spinal needle. | Procedure or surgery | Group P |
| Conventional landmark guided midline spinal anaestheticSpinal anaesthesia was administered based on conventional landmark based midline approach. | Procedure or surgery | Group C |
Primary outcome
Number of passes
Time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
The number of passes, defined as the number of forward advancements of the spinal needle in a given interspinous space (i.e. withdrawal and redirection of spinal needle without exiting the skin)
10 secondary outcomes
Number of spinal needle insertion attempts
Time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Blood in spinal needle
Time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Time for identifying landmarks
Time frame: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete
Time taken for performing spinal anesthetic
Time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Incidence of radicular pain
Time frame: Up to 24 hours after administration of spinal anaesthetic
Presence of paresthesia
Time frame: Up to 24 hours after administration of spinal anaesthetic
Grading of palpated landmarks
Time frame: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete
Peri-procedural VAS scores of pain at injection site
Time frame: up to 30 minutes following spinal anaesthetic injection and prior to sedation
peri-procedural discomfort scores
Time frame: up to 30 minutes following spinal anaesthetic injection and prior to sedation
Level of block
Time frame: 15 minutes after spinal anaesthetic injection
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 24 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.
Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD principal investigator
Cork University 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 pre-procedure ultrasound guided paramedian spinal and Conventional landmark guided midline spinal anaesthetic in people with Anaesthesia, run by Cork University Hospital at 1 site in Ireland.
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 24 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 Ireland. 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?
Number of passes (time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic). 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 24 Jun 2014.