The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
Primary Purpose
Hypotension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Position
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension focused on measuring spinal anesthesia, hypotension, pregnancy
Eligibility Criteria
Inclusion Criteria:
- Singleton pregnancy
- Term gestation
- Scheduled cesarean delivery
- Spinal anesthesia for delivery
Exclusion Criteria:
- Significant fetal concerns
- Polyhydramnios
- Macrosomia
- Morbid obesity (BMI >40)
- Chronic hypertension
- Gestational hypertension
- Preeclampsia
- Type 1 diabetes
- Contraindications to spinal anesthesia
Sites / Locations
- Beth Isreal Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Lateral
Sitting
Recline
Arm Description
patient placed in the lateral postion for spinal anesthesia
patient placed in the sitting position for spinal anestheisa, then supine
patient placed in the sitting position for spinal anesthesia administration. After spinal placed, the patient turned to a 30-degree upperbody tilt, followed by a slow recline to supine over 5 minutes
Outcomes
Primary Outcome Measures
change in blood pressure
percentage change in blood pressure after spinal anesthesia
Secondary Outcome Measures
IV fluid administration
Difference in IV fluid requirements
Full Information
NCT ID
NCT02146898
First Posted
May 19, 2014
Last Updated
January 3, 2017
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02146898
Brief Title
The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
Official Title
The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators intend to study the impact of patient positioning on the changes in blood pressure after spinal anesthesia for cesarean delivery. The investigators hypothesized that the changes in blood pressure relate to the speed with which the spinal medication rises. By slowing the rise of spinal anesthesia, the investigators believe that the incidence and severity of hypotension might be reduced.
Detailed Description
Spinal anesthesia is the most commonly used anesthetic for cesarean delivery. In part, this is due to the ease of administration, reliability and low rates of adverse effects. Additionally, the avoidance of general anesthesia allows the parturient to participate in the birth experience, despite being in surgery.
Although hyperbaric local anesthetic solutions have a remarkable record of safety, their use is not totally without risk. The side effects of spinal anesthesia are well described, but most notably include hypotension (low blood pressure). Spinal hypotension is primarily due to the vasodilatory effects of local anesthetics, and would occur in virtually all women if not prevented or treated.
The incidence of hypotension in both the literature and in clinical practice ranges from 30% to 50% of all patients. Recent literature using a continuous, non-invasive blood pressure monitor suggests that hypotension occurs with greater frequency and may be associated with a higher incidence of adverse effects to either mother or fetus. The incidence and degree of hypotension have been associated with fetal acidosis, which is a sign of either poor perfusion of the placental bed, or increased metabolism due to the blood pressure medications.
The most effective treatment for spinal hypotension is uterine displacement using a hip wedge; the use of a hip wedge after spinal anesthesia is a standard of care. Other treatment, including fluid administration of either crystalloid or colloid, are either partially effective, clinical impractical, or result in administering large doses of medications that may have negative effects on the fetus.
Epidural anesthesia is associated with a reduction in the incidence and severity of hypotension compared with spinal anesthesia. This is believed to be due to the slower onset of sympathetic blockade with epidural anesthesia; this slow onset allows the physiologic compensation to changes in blood pressure. Unfortunately, the slower onset and lower reliability of epidural anesthesia prevents routine use in clinical practice for cesarean delivery.
The investigators hypothesize that the position patients are in during spinal placement might play a role in the severity of maternal hypotension. Interestingly, very few studies have investigated this posibility. Gori, et al. (1) studied influence of seated versus lateral positioning for spinal placement in Cesarean section. They found no significant differences in onset times, Bromage score for motor block, recovery dynamics, and use of ephedrine in two different positions; however, they did not compare the incidence and severity of spinal hypotension. Yun, et al. (2) found that the severity and duration of hypotension were greater when hyperbaric bupivacaine and fentanyl were induced in the sitting position compared to lateral.
Of notice, in all these studies, the authors focused on the immediate positions when the spinal mediation was injected; none has examined the effect of positioning after injection during phase when spinal anesthesia is rising.
Density differences between intrathecal injectate and CSF may explain the observed postural differences in extent of sensory block. Thus, the height of spinal anesthesia blockade could be affected by patient positioning during and after spinal injection. A small incline in positioning immediately after spinal injection may slow the rise of spinal blockade without affecting the duration of spinal anesthesia. In the current protocol, the investigators hypothesize that by slowing the rise of spinal anesthesia, the investigators might reduce the severity of hypotension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
spinal anesthesia, hypotension, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lateral
Arm Type
Active Comparator
Arm Description
patient placed in the lateral postion for spinal anesthesia
Arm Title
Sitting
Arm Type
Active Comparator
Arm Description
patient placed in the sitting position for spinal anestheisa, then supine
Arm Title
Recline
Arm Type
Active Comparator
Arm Description
patient placed in the sitting position for spinal anesthesia administration. After spinal placed, the patient turned to a 30-degree upperbody tilt, followed by a slow recline to supine over 5 minutes
Intervention Type
Other
Intervention Name(s)
Position
Primary Outcome Measure Information:
Title
change in blood pressure
Description
percentage change in blood pressure after spinal anesthesia
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
IV fluid administration
Description
Difference in IV fluid requirements
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
IV pressor requirements
Description
Requirements for IV administration of vasopressors
Time Frame
20 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Singleton pregnancy
Term gestation
Scheduled cesarean delivery
Spinal anesthesia for delivery
Exclusion Criteria:
Significant fetal concerns
Polyhydramnios
Macrosomia
Morbid obesity (BMI >40)
Chronic hypertension
Gestational hypertension
Preeclampsia
Type 1 diabetes
Contraindications to spinal anesthesia
Facility Information:
Facility Name
Beth Isreal Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
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