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A Study Comparing Two Spinal Techniques for for Cesarean Delivery Anesthesia

Primary Purpose

Hypotension, Headache

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wiley Spinal Catheter
Spinal Anesthesia Group (SAG)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Class I, II patients
  • 18-45 year of age
  • Uncomplicated singleton, term pregnancy
  • Scheduled for Cesarean section

Exclusion Criteria:

  • ASA class 3 and above
  • Morbid obesity (BMI>40 kg/m2)
  • Postpartum tubal ligation after cesarean
  • Hypersensitivity and/or prior reaction to opioids
  • Ineffective spinal
  • Conversion to general anesthesia
  • Multiple gestation pregnancy
  • Emergency C-section
  • Contraindication to regional anesthesia
  • History of chronic opioid use

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

spinal anesthesia group (SAG)

The WSCG (wiley spinal catheter group)

Arm Description

Participants will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position.

The WSCG (wiley spinal catheter group) will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position.

Outcomes

Primary Outcome Measures

Blood pressure maintenance
Vasopressor use

Secondary Outcome Measures

Post-spinal Headache
Postoperative pain, wound hyperalgesia and perfusion
CSF and blood biochemical nociceptive and inflammatory mediators

Full Information

First Posted
October 5, 2009
Last Updated
October 7, 2015
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00990574
Brief Title
A Study Comparing Two Spinal Techniques for for Cesarean Delivery Anesthesia
Official Title
Spinal Anesthesia for Cesarean Delivery: The Wiley Spinal Catheter Intermittent Bolus Technique Versus Single Shot Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
device not found to be adequate
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare single shot versus sequential bolus spinal technique via a catheter in patients undergoing Cesarean Section. We aim to determine which technique results in less blood pressure reduction and subsequent vasopressor use. Other study endpoints include the incidence of maternal post dural puncture headaches and nausea and vomiting. In addition blood and CSF will be collected to see if biochemical mediators are related to wound hyperalgesia and healing.
Detailed Description
Following IRB approval, the investigators plan to enroll 60 pregnant women (30 in the spinal anesthesia group (SAG), and 30 patients in the Wiley spinal catheter group (WSCG)) undergoing cesarean delivery. Patients will be randomly assigned to one of these two groups. Both groups will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position. The SAG will have their drugs dosed intrathecally as a "single shot" while still in the sitting position. The WSCG will have a Wiley spinal catheter placed, but it will not be dosed until the patient is in the supine position with left uterine displacement. Both groups will be dosed with 12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine. While the SAG will receive their total dose as a one time bolus, the WSCG patients will receive the medication in sequential doses. Blood pressure will be monitored every minute after spinal medication is administered until delivery of the baby. Thereafter, it will be monitored at least every 3 minutes. Any blood pressure below 90, 80 and 70% of baseline will be treated with 50, 100 and 150 mcg of phenylephrine, respectively. In the WSC group, cerebrospinal fluid (CSF) will be collected prior to intrathecal dosing, and then 1 and 5 hours post-spinal utilizing a three-way stopcock incorporated into the IT catheter. All CSF samples will be analyzed for various nociceptive and inflammatory biochemical mediators using a multiplex bead array immunoassay plate. Venous blood will be drawn prior to spinal dosing and 5 hours afterwards to measure the same cytokines and biochemical mediators. Participants will be followed for 2 days post cesarean section to monitor for episodes of a spinal or post dural puncture headache (PDPH). A PDPH is defined as an occipital or frontal headache brought on by the erect posture and relieved when the supine posture is assumed. If the PDPH persists longer than 24 h with the same severity, an epidural blood patch (EBP) will be performed. The decision to perform an EBP will always be made by a staff anesthesiologist. Headaches will be monitored daily for 3 days, then at 1 week. Patients will be treated for their headaches per standard methods by an anesthesiologist not involved in the study. Postoperative pain will be recorded at rest and sitting at 1, 5, 24, 48h post-cesarean using a VPS 0-10 (0=no pain, 10=worse pain imaginable) measure. The area of secondary hyperalgesia surrounding the wound will be measured at 48hours with a von Frey filament. A color laser Doppler will also be used to assess vascular perfusion of the wound 48 hours after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Headache

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spinal anesthesia group (SAG)
Arm Type
Active Comparator
Arm Description
Participants will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position.
Arm Title
The WSCG (wiley spinal catheter group)
Arm Type
Active Comparator
Arm Description
The WSCG (wiley spinal catheter group) will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position.
Intervention Type
Device
Intervention Name(s)
Wiley Spinal Catheter
Intervention Description
The WSCG (wiley spinal catheter group) will have a Wiley spinal catheter placed, but it will not be dosed until the patient is in the supine position with left uterine displacement. Participants will receive the medication (12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine) in sequential doses.
Intervention Type
Device
Intervention Name(s)
Spinal Anesthesia Group (SAG)
Intervention Description
The SAG (spinal anesthesia group) will have their drugs (12 mg of 0.75% hyperbaric bupivacaine, 10 mcg of fentanyl, and 100 mcg of morphine) dosed intrathecally as a "single shot" while still in the sitting position.
Primary Outcome Measure Information:
Title
Blood pressure maintenance
Time Frame
Spinal to End Surgery
Title
Vasopressor use
Time Frame
Spinal to End Surgery
Secondary Outcome Measure Information:
Title
Post-spinal Headache
Time Frame
1 week
Title
Postoperative pain, wound hyperalgesia and perfusion
Time Frame
48 h
Title
CSF and blood biochemical nociceptive and inflammatory mediators
Time Frame
5 h

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) Class I, II patients 18-45 year of age Uncomplicated singleton, term pregnancy Scheduled for Cesarean section Exclusion Criteria: ASA class 3 and above Morbid obesity (BMI>40 kg/m2) Postpartum tubal ligation after cesarean Hypersensitivity and/or prior reaction to opioids Ineffective spinal Conversion to general anesthesia Multiple gestation pregnancy Emergency C-section Contraindication to regional anesthesia History of chronic opioid use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Carvalho
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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A Study Comparing Two Spinal Techniques for for Cesarean Delivery Anesthesia

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