The Effects of a Head Elevated Ramped Position During Elective Cesarean Delivery After Combined Spinal Epidural (CSE) Anesthesia

NCT01161693 | Completed

• 1 other identifier: H10-01157
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 (Control), Head Elevated in Ramped Position immediately after regional anesthesia (HERP), or Head Elevated Ramped Position horizontally- Horizontal until establishment of anesthesia and then head elevated for the surgical procedure (HERP-H). The subjects will be monitored for blood pressure changes (hypotension), comfort levels and time to adequate level of the anesthetic block obtained with the CSE. The study will determine if positioning a parturient in the ramped position using an elevation pillow will significantly increase the time for anesthesia to reach the dermatome level of T4 as well as whether it increases maternal comfort and provides a better airway position for the parturient.

Conditions

Cesarean Section

Keywords

Cesarean section; spinal anesthesia; CSE; ramped up position; TROOP pillow; elevation pillow; maternal comfort; Maternal Comfort after CSE during elective Cesarean Section in relation to adequate height of Anesthetic Block

Outcome Measures

Primary Outcomes (1)

• length of time for anesthetic block to reach T4

  Our primary outcome is the length of time for anesthetic block to reach T4 from time of subarachnoid injection of local anesthetic, tested with ice

  11 months

Secondary Outcomes (1)

• Need for epidural supplementation

  11 months

Study Arms (3)

Standard pillow under head

NO INTERVENTION

Control (C) - Standard pillow under head (figure 1) as is the usual practice at BC Women's Hospital

Device: TROOP® elevation pillow

Troop Elevation Pillow in horizontal position-HERP

ACTIVE COMPARATOR

TROOP® elevation pillow (designed by an American bariatric anaesthesiologist Dr Craig Troop, plastic covered foam pillow with an elevation angle of 20 degrees which can simply be placed on the operating table)

Device: TROOP® elevation pillow

Troop Elevation Pillow in horizontal position-HERP-H

ACTIVE COMPARATOR

Operating table tilted in Trendelenberg position so angle of Troop pillow is parallel to floor (figure 3) until establishment of adequate block and then the bed levelled to horizontal i.e. to the same position as group (HERP) (figure 2)

Device: TROOP® elevation pillow

Interventions

TROOP® elevation pillow DEVICE

Maternal Comfort after CSE during elective Cesarean Section in relation to adequate height of Anesthetic Block

Standard pillow under head

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Women's Hospital, Dept of Anesthesia

Vancouver, British Columbia, V6H 3N1, Canada

Location

Study Officials

• Joanne Douglas, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 13, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 10, 2011

Record last verified: 2011-08

Locations

CA (1)