Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Manitoba
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Recovery room length of stay
Study Overview
Brief Summary
We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of hypotension, and compare pain control and maternal satisfaction during and after cesarean section.
We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to interact with baby in the OR.
Detailed Description
Hypothesis
It is hypothesized that low dose spinal anesthesia can provide equivalent anesthesia for cesarean section as higher conventional dose spinal anesthesia, with less hypotension, faster recovery and enhanced maternal satisfaction.
Patient Population
Adult females having elective, repeat cesarean sections who have given informed consent.
Exclusion Criteria
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult females having elective, repeat cesarean sections who have given informed consent.
Exclusion Criteria
- •• Contraindications to dural puncture
- •Elective C/S presenting in labour or with rupture of membranes
- •Placenta previa or accrete
Arms & Interventions
Low Dose Spinal
Hyperbaric bupivacaine 4.5mg with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be positioned right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section.
Intervention: Bupivacaine 4.5 (Drug)
Low Dose Spinal
Hyperbaric bupivacaine 4.5mg with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be positioned right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section.
Intervention: Morphine (Drug)
Low Dose Spinal
Hyperbaric bupivacaine 4.5mg with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be positioned right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section.
Intervention: Fentanyl (Drug)
Control Spinal Group
Hyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section.
Intervention: Bupivacaine 9 (Drug)
Control Spinal Group
Hyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section.
Intervention: Morphine (Drug)
Control Spinal Group
Hyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section.
Intervention: Fentanyl (Drug)
Outcomes
Primary Outcomes
Recovery room length of stay
Time Frame: Current recovery room average length of stay is 4 hours
The primary endpoint is the expected reduction in the Recovery Room length of stay. Based on a predicted 50-100% reduction in length of stay, alpha 0.05, power of 80%, and given an anticipated drop-out rate of 10%, a sample size of n = 20 study patients per group is required.
Secondary Outcomes
- Hemodynamics(Average duration of surgery is 100 minutes)