Status:
COMPLETED
The Effects of a Head Elevated Ramped Position During Elective Cesarean Delivery After Combined Spinal Epidural (CSE) Anesthesia
Lead Sponsor:
University of British Columbia
Conditions:
Cesarean Section
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
This study will randomly allocate 180 women undergoing elective C-sections under combined spinal epidural (CSE) Anesthesia at BC Women's Hospital to one of three groups: Standard Pillow under Head (Co...
Detailed Description
The majority of elective and emergency cesarean deliveries are done under neuraxial anesthesia (spinal, epidural, combined spinal epidural) where the nerves to the lower half of the body are anestheti...
Eligibility Criteria
Inclusion
- Pregnancy greater than 37 weeks gestation
- ASA (American Society of Anaesthesiologists) I and II classification of health. Class I a normal healthy patient and II a patient with mild systemic disease (i.e. mild asthma)
- Mothers presenting to the assessment unit with ruptured membranes or in the early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery.
- Potential subjects need to be able to read and understand English, unless an independent translator is available.
Exclusion
- Women having general anesthesia
- Mothers in active labour - 3cm or more dilated with regular coordinated contractions (3 in 10 minutes)
- ASA classification 3 or above
- Emergency cesarean delivery for fetal heart rate abnormalities
- Maternal age \<19
- BMI \>40. Obesity makes it more difficult to site the combined spinal epidural which could lead to delay in positioning the patient quickly following subarachnoid block. Obesity can result in increased venal caval compression in the supine wedge position causing epidural venous plexus engorgement and dural sac compression which may result in a high block. A later study will look at the effects of positioning in the obese patient
- Mothers with a history of known tolerance to opioids
- Uterine over distension- polyhydramnios, twin pregnancy and estimated fetal weight of over 4kg by ultrasound scan -Uterine over distension can result in increased aortocaval compression which may lead to engorgement of the epidural venous plexus and dural sac compression which may result in a high block.
- Height over 180cm and below 150cm
- Women presenting for urgent caesarean delivery will be excluded if there is less than 60 minutes between the time that the researcher can approach them regarding the study and the time that they will have their surgery.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01161693
Start Date
July 1 2010
End Date
May 1 2011
Last Update
August 10 2011
Active Locations (1)
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1
BC Women's Hospital, Dept of Anesthesia
Vancouver, British Columbia, Canada, V6H 3N1