- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03315845
Neuraxial Anaesthesia: Does BMI Relate to Ease of Neuraxial Anaesthesia?
Neuraxial Anaesthesia: Does BMI Relate to Palpability of Bony Landmarks and Are Standard Needles a Suitable First Choice in Patients With BMI>30kg/m2
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Recorded BMI >30kg/m2; ability to give consent; non-emergency cases.
Exclusion Criteria:
- Previous metal work to lumbar spine.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Palpability of bony landmarks for neuraxial anaesthesia
Tidsramme: 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.
|
4 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ultrasonographic distance from skin to posterior epidural complex
Tidsramme: 4 months
|
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.
|
4 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Kevin McKeating, National Maternity Hospital, Ireland
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- Srinivasan KK, Lee PJ, Iohom G. Ultrasound for neuraxial blockade. Med Ultrason. 2014 Dec;16(4):356-63.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NationalMHI
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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