Obesity Clinical Trial
Official title:
The Clinical Evaluation of a Novel Ultrasound Probe to Guide the Insertion of Central Regional Anaesthesia Using a Regional Anaesthetic Needle Modified to Aid Insertion Under Ultrasound Guidance in Morbidly Obese Women Undergoing Elective Caesarean Section
The study will establish whether the use of ultrasound scanning with a purpose built probe
will aid the insertion of the needles for epidural and spinal anaesthesia for obese women
undergoing elective caesarean section The study group will be 46 obese women (defined by the
ratio of height to weight) at time of initial booking ultrasound scan, undergoing routine
caesarean section with no serious illnesses that are both willing and able to provide
informed consent prior to spinal epidural anaesthesia. Patients will be excluded if they
have signs or symptoms of systemic or local infection, if they have a history of previous
spinal surgery, a blood clotting abnormities.
In order to evaluate the clinical usefulness of the ultrasound probe a randomised comparison
of the traditional clinical methods of feeling the bones of the spine and ultrasound guided
insertion of a combined spinal epidural anaesthetic will be undertaken. The rodiera tiped
17/18G 90mm tuohy needle and 123mm 27G spinal needle manufactured by Sarstedt will be the
regional needles used for the combined spinal epidural anaesthetic. Randomisation into two
groups (ultrasound guided needle insertion and feeling the bones) will be by computer
generated random sequence. This information will be recorded in sealed envelopes and placed
in the ward. Patients who meet the inclusion criteria and who consent immediately prior to
caesarean section will be sequentially assigned a number that will correspond to a sealed
envelope. The main aim of the study will be to detect any difference in time taken to insert
epidural catheter via the needle in the patients back. The other factors measured will be
the number of times the skin is punctured and bone touched by the needle, number of
conversions from regional (spinal epidural) to general anaesthesia, patient satisfaction
scores, requirement for extra local anaesthetic following initial blockade during Caesarean
section.
The factors will be compared by student t-test using Statistica6 (StatSoft,Inc.(2001).
STATISTICA (data analysis software system), version 6. www.statsoft.com). A population of 46
patients will be required assuming a mean time for inserting a combined spinal epidural
without
Study objective:
The clinical evaluation of a novel ultrasound probe to guide the insertion of central
regional anaesthesia using a regional anaesthetic needle modified to aid insertion under
ultrasound guidance in morbidly obese women undergoing elective caesarean section. - (full
title) The clinical evaluation of a novel ultrasound probe-(short title)
Background and Rationale:
Cases of trauma to the conus medularis following spinal anaesthesia have been highlighted
recently by Reynolds1. A second report in the same vein described the inaccuracy of using
Tuffier's line between the iliac crests to identify a safe lumbar interspace2. As suspected
by many clinicians, precise lumbar interspace identification by palpation is prone to error.
Broadbent2 et al confirmed this showing that anaesthetists were only 29% accurate, as
determined by MRI/ (Ultrasonography was not investigated by Broadbent). The inaccuracy was
corroborated by Furness et al3. who showed that clinical identification by anaesthetists
using palpation was 30% accurate, as assessed by lumbar spine X-ray. In contrast, in the
latter study, placement of markers using ultrasonography at L3-4 interspace was 71%
accurate, a figure which is comparable with the 76% accuracy in the preliminary study
described below . It should be noted in the Furness study that ultrasonography was performed
by a consultant radiologist but in our study an anaesthetist performed the procedure. The
Broadbent and Furness studies both documented that identification by anaesthetists using
palpation was often inaccurate by two, three or four interspaces. Using ultrasound, in both
the Furness3 study and our study, markers were always within one interspace of the intended
position.
Morbid obesity is an increasingly prevalent problem in obstetric practice. Landmarks are
often impalpable in obese patients making insertion of epidurals problematic. Thus there is
clear clinical need to develop a safe efficient way to administer epidural anaesthesia. The
central hypothesis of our application is that ultrasonic visualisation of the landmarks will
aid insertion. Further it is possible to develop and manufacture a probe for general use by
anaesthetists that will improve current clinical practice in this problematic area.
Initial study to investigate accuracy ultrasound by non radiologist:
An exploratory study was undertaken to determine the precision with which an anaesthetist
could identify the correct L3-4 interspace using ultrasonography. Twenty-three
ultrasonographic examinations of lumbar spine were performed by an anaesthetic senior house
officer with minimal training on patients undergoing an elective MRI scan of the lumbar
spine. Seventeen patients were eligible for inclusion in this study. Patients' median age
was 47 years, and body mass index 27 kg/m2. In 13 of the 17 (76%) patients, the SHO using
ultrasonography was able to place a marker correctly at the L3-4 interspace as indicated by
MRI. In four patients, the marker was at the L2-3 interspace. In five of the 17 patients
apposition of spinous processes was noted on MRI scan and it was in three of these patients
that the marker was at the L2-3 interspace.
Ultrasound has been used to aid the insertion of central neuraxial anaesthesia on three
occasions. (Watson et al unpublished). The 3 cases below describe the successful ultrasound
assisted insertion of three neuroaxial blocks to allow both emergency and elective caesarean
section. The first two reports are based on the same woman undergoing emergency and elective
section during two consecutive pregnancies complicated by obesity and pre-eclampsia. The
third case report was complicated by the previous spinal fusion surgery for a lumbar disc
prolapse.
Aim:
To determine if the novel ultrasound transducer provides a method of reducing the time taken
to insert a combined spinal epidural anaesthetic in obese women undergoing elective
caesarean section
Study population:
Sample Population:
The maternity hospitals involved in this trial have in excess of 25,000 deliveries per year
and a significant percentage of these mothers come from under privileged backgrounds with a
high incidence of morbid obesity. A study population of 46 patients will be recruited from
those women undergoing elective caesarean section
Study procedures
Randomisation of patients:
Randomisation into two groups will be by computer generated block randomisation method. This
information will be recorded in sealed envelopes and placed in the labour ward at princess
royal maternity. Patients who meet the inclusion criteria and who consent will be
sequentially assigned a number that will correspond to a sealed envelope.
Method:
Prior to the study starting we will recruit and consent 10 elective section patients to
optimise the quality control of for imaging with the split array ultrasound transducer.
In order to evaluate the clinical efficacy of the ultrasound probe a randomised comparison
of the traditional clinical methods of palpation and ultrasound guided insertion of a
(CSE)combined spinal/epidural anaesthetic will be undertaken. The combined spinal epidural
(17/18G 90mm rodiera tiped tuohy needle and 123mm 27G spinal needle manufactured by Sarstedt
will be used for all patients and all the tuohy needles will be sand and bead blasted,
desterilised and repackaged prior to use. All patients will have a spinal anaesthetic 2.4mls
of heavy bupivacaine and a 22G epidural catheter sited via a 16G tuohy needle with
diamorphine or fentanyl. All anaesthetic procedures will be undertaken by the same
experienced anaesthetist. However those patients in the ultrasound group will have the
insertion of the tuohy needle guided by ultrasound and the will be compared to the current
method of palpation. All patients will then undergo elective caesarean section. Patient's
having an ultrasound inserted using palpation may be transferred to the ultrasound guided
group after 30 minutes of attempted insertions or at the discretion of the anaesthetist
treating the patient.
Withdrawal of patients from study:
Any patient may withdraw from the study at any time without giving any reason or
justification.
Any protocol violation will result in the patient being immediately withdrawn from the study
If the patient requires emergency caesarean section they will be withdrawn from the study If
the patient is in labour prior to their intended date of operative delivery they will be
withdrawn from the study Any patient who does not undergo an caesarean section will be
withdrawn from the study
Statistical considerations:
Primary end points:
The primary end point will be time taken to insert an epidural catheter.
Secondary end points:
The number of times the skin is punctured The number of times the cortex of bone touched by
the epidural needle The number of conversions from regional (central-neuraxial) to general
anaesthesia Patient satisfaction scores immediately post op and at 30 minutes post op The
volume and concentration of supplementary local anaesthetic administration following primary
spinal blockade during caesarean section Number of needle advancements
Number of conversions to general anaesthesia
Number of 'dry spinal taps'
Patient numbers:
A population of 46 patients will be required assuming a mean time for inserting a combined
spinal epidural without ultrasound guidance of 15 minutes and with ultrasound guidance of 10
minutes with a standard deviation of 5 minutes for both groups ( power=90%, alpha error
=0.05).
Assessment of Safety and Efficacy:
The time taken to perform the CSE will be recorded from the moment the skin is sterilised to
the moment the epidural catheter has been fixed to the skin. A record of the number of
attempts and number of times bone is encountered by the needle will be recorded. If patients
in the palpation group require ultrasound assistance to locate the epidural space this will
also be recorded. Drugs administered both systemically and intrathecally or epidurally will
be documented. Patients will be assessed immediately after insertion of the CSE with regard
to comfort during the procedure and and pain experienced. They shall also be reassessed 30
minutes postoperatively to ascertain their overall satisfaction of the technique for the
surgery, to ensure no pain was experienced during the operation. They should also be visited
on the first postoperative day, specifically to look for any complications of the CSE such
as headache or neuropraxia, and should receive a final check prior to discharge at 5 days to
ensure no adverse events have occurred.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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