NCT03315845

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2018

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

October 17, 2017

Last Update Submit

October 22, 2017

Conditions

Keywords

BMIobstetric anaesthesianeuraxial anaesthesianeuraxial ultrasounddifficult neuraxial anaesthesia

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.

Also known as: Neuraxial ultrasound

Eligibility Criteria

Age16 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsObstetric patients.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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: 25036283BACKGROUND
  • Ansari 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: 24768303BACKGROUND
  • Srinivasan KK, Lee PJ, Iohom G. Ultrasound for neuraxial blockade. Med Ultrason. 2014 Dec;16(4):356-63.

    PMID: 25463890BACKGROUND
  • Grau 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: 11915069BACKGROUND
  • Carnie 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: 12059829BACKGROUND
  • Gnaho 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: 22793967BACKGROUND
  • Seligman 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: 28858898BACKGROUND
  • Balki 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

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin McKeating

    National Maternity Hospital, Ireland

    STUDY DIRECTOR

Central Study Contacts

Moninne Creaney, MBBChBAOFCAI

CONTACT

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