An observational study in Obesity, Neuraxial Ultrasound and Obstetric Anaesthesia, sponsored by National Maternity Hospital, Ireland. Status unknown. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-24.
Sponsored by National Maternity Hospital, Ireland · Observational
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 100 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →National Maternity Hospital, Ireland is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Obstetric patients with BMI >30kg/m2, presenting in a non-emergency situation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 4 months
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.
Time frame: 4 months
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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National Maternity Hospital, Ireland