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
Status | Completed |
Enrollment | 42 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Elective Caesarean section > 38/52 gestation - BMI at booking scan (circia 13/52 gestation)>=35 - ASA = 1,2 or 3 patients only Exclusion Criteria: - Abnormal clotting screen (coagulopathy) or thrombocytopenia ( < 100,000) - Unable to give informed consent to combined spinal epidural anaesthesia - Previous spinal surgery or known spinal pathology - Signs, symptoms or laboratory evidence of local infection or systemic sepsis |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Princess Royal maternity | Glasgow | Scotland |
United Kingdom | Queen mother's maternity | Glasgow | Scotland |
United Kingdom | Southern general maternity hospital | Glasgow | Scotland |
United Kingdom | Paisley maternity hospital | Paisley | Scotland |
United Kingdom | Wishaw Maternity hospital | Wishaw | Scotland |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary end point will be time taken to insert an epidural catheter. | During the c-section | No | |
Secondary | The number of times the skin is punctured | anaesthesia induction | No | |
Secondary | The number of times the cortex of bone touched by the epidural needle | anaesthesia induction | No | |
Secondary | The number of conversions from regional (central-neuraxial) to general anaesthesia | anaesthesia induction | No | |
Secondary | Patient satisfaction scores immediately post op and at 30 minutes post op | 30mins post operatively | No | |
Secondary | The volume and concentration of supplementary local anaesthetic administration following primary spinal blockade during caesarean section | intraoperatively | No | |
Secondary | Number of needle advancements | Induction of anaesthesia | No | |
Secondary | Number of conversions to general anaesthesia | induction of anaesthesia | No | |
Secondary | Number of 'dry spinal taps' | induction of anaesthesia | No |
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