ObesityNCT03315845
Neuraxial Anaesthesia: Does BMI Relate to Ease of Neuraxial Anaesthesia?
An observational study of Obesity and Neuraxial Ultrasound, run by National Maternity Hospital, Ireland.
Trial summary
Neuraxial anaesthesia can be more difficult and associated with more complications if the patient's bony landmarks are difficult to palpate. They are more likely to be difficult to palpate if a patient has a high Body Mass Index (BMI), (>30kg/m2). Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Neuraxial Ultrasound, Obstetric Anaesthesia
- What is being tested?
- Palpation of bony landmarks for neuraxial anaesthesia.
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2017to 9 Jan 2018
- Phase
- Observational
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Obstetric patients with BMI >30kg/m2, presenting in a non-emergency situation.
Who may be able to join
- Recorded BMI >30kg/m2; ability to give consent; non-emergency cases.
Who cannot join
- Previous metal work to lumbar spine.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neuraxial Anaesthesia: Does BMI Relate to Palpability of Bony Landmarks and Are Standard Needles a Suitable First Choice in Patients With BMI>30kg/m2
Neuraxial anaesthesia can be more difficult and associated with more complications if the patient's bony landmarks are difficult to palpate. They are more likely to be difficult to palpate if a patient has a high Body Mass Index (BMI), (>30kg/m2). The depth that the spinal or epidural needle must be inserted is usually longer in these patients with high BMIs. We wish to palpate the backs of at least 100 such patients to see how many of them have impalpable bony landmarks. We then wish to use ultrasound to measure the distance from skin to the posterior epidural complex to discover if this length is longer than the standard needle length. If it is longer in the majority of people we study, we will recommend changing standard practice to start using a longer needle for all first attempts at neuraxial anaesthesia in this patient population.
Read the detailed description
Complications rates including failure are higher in obese patients undergoing anaesthesia procedures. Anaesthetists have adopted the use of ultrasound to assist in overcoming these difficulties. Neuraxial ultrasound is proving to be beneficial in those patients in whom identification of interspinous spaces is difficult and most of these patients are obese.
In our institution, there is a 'standard practice' for neuraxial procedures, with a 'standard' needle used for first attempts (Whitacre 25G 90mm for spinal, Tuohy 18G 80mm for epidural). If the operator has not reached the desired space (spinal or epidural) with the needle inserted to 8cm, a longer needle is then considered for further attempts. This exposes the patient to at least one extra neuraxial needle insertion. Studies have shown that increased needle insertions and redirections are associated with increased complications.
We hypothesised that a large number of patients with BMI>30kg/m2 would have a depth of spinal/epidural space that is greater than the length of the 'standard' needle used. Therefore we suggest that practice should change to use the longer needle or a combined spinal-epidural on the first attempt in these patients.
To test our hypothesis, we will assess the ease of palpation of the following anatomical landmarks: anterior and posterior iliac crests; lumbar spinous processes; scapulae; and sacral cornua. We will then perform neuraxial sonography of the lumbar spine, measuring depth to epidural space. Finally we will measure waist circumference in those patients with BMI <30kg/m2.
- Conditions
- Obesity, Neuraxial Ultrasound, Obstetric Anaesthesia
- Being tested
- Palpation of bony landmarks for neuraxial anaesthesia.
- Keywords
- BMI, obstetric anaesthesia, neuraxial anaesthesia, neuraxial ultrasound, difficult neuraxial anaesthesia
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palpation of bony landmarks for neuraxial anaesthesia.Other
Also called Neuraxial ultrasound
Manual palpation of anterior and posterior iliac crests; lumbar spinous processes; scapulae; and sacral cornua.
Ultrasound of neuraxial anatomy to assess depth to epidural space.
What is being measured
The primary outcome is the main question the study is designed to answer.
Palpability of bony landmarks for neuraxial anaesthesia
The percentage of patients with BMI>30kg/m2 who have difficult or impalpable bony landmarks including: lumbar spinous processes; anterior and posterior iliac spines; scapulae; and sacral cornua.
Measured: 4 months
Secondary outcomes (1)
Ultrasonographic distance from skin to posterior epidural complex
To use sonography to measure the distance from skin to the dural complex in these patients and quantify the percentage whose distance is greater than the length of the standard needle.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start23 Oct 2017 (estimated)
- Primary completion9 Jan 2018 (estimated)
- Study completion9 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Maternity Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moninne Creaney, National Maternity Hospital, Ireland
- Investigators
- Kevin McKeating, Study director, National Maternity Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315845
- Sponsor's protocol ID
- NationalMHI
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.
PubMed 25036283Ansari T, Yousef A, El Gamassy A, Fayez M. Ultrasound-guided spinal anaesthesia in obstetrics: is there an advantage over the landmark technique in patients with easily palpable spines? Int J Obstet Anesth. 2014 Aug;23(3):213-6. doi: 10.1016/j.ijoa.2014.03.001. Epub 2014 Mar 12.
PubMed 24768303Srinivasan KK, Lee PJ, Iohom G. Ultrasound for neuraxial blockade. Med Ultrason. 2014 Dec;16(4):356-63.
PubMed 25463890Grau T, Leipold RW, Delorme S, Martin E, Motsch J. Ultrasound imaging of the thoracic epidural space. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):200-6. doi: 10.1053/rapm.2002.29239.
PubMed 11915069Carnie J, Boden J, Gao Smith F. Prediction by computerised tomography of distance from skin to epidural space during thoracic epidural insertion. Anaesthesia. 2002 Jul;57(7):701-4. doi: 10.1046/j.1365-2044.2002.02572_4.x.
PubMed 12059829Gnaho A, Nguyen V, Villevielle T, Frota M, Marret E, Gentili ME. Assessing the depth of the subarachnoid space by ultrasound. Rev Bras Anestesiol. 2012 Jul;62(4):520-30. doi: 10.1016/S0034-7094(12)70150-2.
PubMed 22793967Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.
PubMed 28858898Balki M, Lee Y, Halpern S, Carvalho JC. Ultrasound imaging of the lumbar spine in the transverse plane: the correlation between estimated and actual depth to the epidural space in obese parturients. Anesth Analg. 2009 Jun;108(6):1876-81. doi: 10.1213/ane.0b013e3181a323f6.
PubMed 19448216
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuraxial Anaesthesia: Does BMI Relate to Palpability of Bony Landmarks and Are Standard Needles a Suitable First Choice in Patients With BMI>30kg/m2
- ClinicalTrials.gov ID
- NCT03315845
- Acronym / sponsor ID
- NationalMHI
- Conditions
- Obesity, Neuraxial Ultrasound, Obstetric Anaesthesia
- Keywords
- BMI, obstetric anaesthesia, neuraxial anaesthesia, neuraxial ultrasound, difficult neuraxial anaesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Maternity Hospital, IrelandUniversity, hospital or other
- Study start
- 23 Oct 2017 (estimated)
- Primary completion
- 9 Jan 2018 (estimated)
- Study completion
- 9 Jan 2018 (estimated)
- First posted
- 20 Oct 2017 (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.
Neuraxial anaesthesia can be more difficult and associated with more complications if the patient's bony landmarks are difficult to palpate. They are more likely to be difficult to palpate if a patient has a high Body Mass Index (BMI), (>30kg/m2). The depth that the spinal or epidural needle must be inserted is usually longer in these patients with high BMIs. We wish to palpate the backs of at least 100 such patients to see how many of them have impalpable bony landmarks. We then wish to use ultrasound to measure the distance from skin to the posterior epidural complex to discover if this length is longer than the standard needle length. If it is longer in the majority of people we study, we will recommend changing standard practice to start using a longer needle for all first attempts at neuraxial anaesthesia in this patient population.
Detailed description
Complications rates including failure are higher in obese patients undergoing anaesthesia procedures. Anaesthetists have adopted the use of ultrasound to assist in overcoming these difficulties. Neuraxial ultrasound is proving to be beneficial in those patients in whom identification of interspinous spaces is difficult and most of these patients are obese.
In our institution, there is a 'standard practice' for neuraxial procedures, with a 'standard' needle used for first attempts (Whitacre 25G 90mm for spinal, Tuohy 18G 80mm for epidural). If the operator has not reached the desired space (spinal or epidural) with the needle inserted to 8cm, a longer needle is then considered for further attempts. This exposes the patient to at least one extra neuraxial needle insertion. Studies have shown that increased needle insertions and redirections are associated with increased complications.
We hypothesised that a large number of patients with BMI>30kg/m2 would have a depth of spinal/epidural space that is greater than the length of the 'standard' needle used. Therefore we suggest that practice should change to use the longer needle or a combined spinal-epidural on the first attempt in these patients.
To test our hypothesis, we will assess the ease of palpation of the following anatomical landmarks: anterior and posterior iliac crests; lumbar spinous processes; scapulae; and sacral cornua. We will then perform neuraxial sonography of the lumbar spine, measuring depth to epidural space. Finally we will measure waist circumference in those patients with BMI <30kg/m2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obstetric patients with BMI >30kg/m2, presenting in a non-emergency situation.
Key inclusion criteria (1 listed)
- Recorded BMI >30kg/m2; ability to give consent; non-emergency cases.
Key exclusion criteria (1 listed)
- Previous metal work to lumbar spine.
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 |
|---|---|---|
| Palpation of bony landmarks for neuraxial anaesthesia.Also: Neuraxial ultrasoundManual palpation of anterior and posterior iliac crests; lumbar spinous processes; scapulae; and sacral cornua. Ultrasound of neuraxial anatomy to assess depth to epidural space. | Other | – |
Primary outcome
Palpability of bony landmarks for neuraxial anaesthesia
Time frame: 4 months
The percentage of patients with BMI>30kg/m2 who have difficult or impalpable bony landmarks including: lumbar spinous processes; anterior and posterior iliac spines; scapulae; and sacral cornua.
1 secondary outcome
Ultrasonographic distance from skin to posterior epidural complex
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Background: PubMed 25036283Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.
- Background: PubMed 24768303Ansari T, Yousef A, El Gamassy A, Fayez M. Ultrasound-guided spinal anaesthesia in obstetrics: is there an advantage over the landmark technique in patients with easily palpable spines? Int J Obstet Anesth. 2014 Aug;23(3):213-6. doi: 10.1016/j.ijoa.2014.03.001. Epub 2014 Mar 12.
- Background: PubMed 25463890Srinivasan KK, Lee PJ, Iohom G. Ultrasound for neuraxial blockade. Med Ultrason. 2014 Dec;16(4):356-63.
- Background: PubMed 11915069Grau T, Leipold RW, Delorme S, Martin E, Motsch J. Ultrasound imaging of the thoracic epidural space. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):200-6. doi: 10.1053/rapm.2002.29239.
- Background: PubMed 12059829Carnie J, Boden J, Gao Smith F. Prediction by computerised tomography of distance from skin to epidural space during thoracic epidural insertion. Anaesthesia. 2002 Jul;57(7):701-4. doi: 10.1046/j.1365-2044.2002.02572_4.x.
- Background: PubMed 22793967Gnaho A, Nguyen V, Villevielle T, Frota M, Marret E, Gentili ME. Assessing the depth of the subarachnoid space by ultrasound. Rev Bras Anestesiol. 2012 Jul;62(4):520-30. doi: 10.1016/S0034-7094(12)70150-2.
- Background: PubMed 28858898Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.
- Background: PubMed 19448216Balki M, Lee Y, Halpern S, Carvalho JC. Ultrasound imaging of the lumbar spine in the transverse plane: the correlation between estimated and actual depth to the epidural space in obese parturients. Anesth Analg. 2009 Jun;108(6):1876-81. doi: 10.1213/ane.0b013e3181a323f6.
- 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.
Kevin McKeating study director
National Maternity Hospital, Ireland
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Neuraxial Ultrasound, run by National Maternity Hospital, 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: status not confirmed, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moninne Creaney, MBBChBAOFCAI (00353879837656, creaneym@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palpability of bony landmarks for neuraxial anaesthesia (time frame: 4 months). 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 NCT03315845, which also lists 8 linked publications.
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 Oct 2017.