Neuraxial Anaesthesia: Does BMI Relate to Ease of Neuraxial Anaesthesia?
1 other identifier
observational
100
0 countries
N/A
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
October 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2018
CompletedOctober 24, 2017
October 1, 2017
3 months
October 17, 2017
October 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 months
Secondary Outcomes (1)
Ultrasonographic distance from skin to posterior epidural complex
4 months
Interventions
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.
Eligibility Criteria
Obstetric patients with BMI \>30kg/m2, presenting in a non-emergency situation.
You may qualify if:
- Recorded BMI \>30kg/m2; ability to give consent; non-emergency cases.
You may not qualify if:
- Previous metal work to lumbar spine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (8)
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.
PMID: 25036283BACKGROUNDAnsari 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.
PMID: 24768303BACKGROUNDSrinivasan KK, Lee PJ, Iohom G. Ultrasound for neuraxial blockade. Med Ultrason. 2014 Dec;16(4):356-63.
PMID: 25463890BACKGROUNDGrau 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.
PMID: 11915069BACKGROUNDCarnie 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.
PMID: 12059829BACKGROUNDGnaho 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.
PMID: 22793967BACKGROUNDSeligman 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.
PMID: 28858898BACKGROUNDBalki 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.
PMID: 19448216BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kevin McKeating
National Maternity Hospital, Ireland
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Moninne Creaney, Specialist Registrar in Anaesthesia
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 20, 2017
Study Start
October 23, 2017
Primary Completion
January 9, 2018
Study Completion
January 9, 2018
Last Updated
October 24, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share