A Study Comparing Two Spinal Techniques for for Cesarean Delivery Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University
ClinicalTrials.gov Identifier:
NCT00990574
First received: October 5, 2009
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Hypotension
Headache
Device: Wiley Spinal Catheter
Device: Spinal Anesthesia Group (SAG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Spinal Anesthesia for Cesarean Delivery: The Wiley Spinal Catheter Intermittent Bolus Technique Versus Single Shot Spinal Anesthesia

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Blood pressure maintenance [ Time Frame: Spinal to End Surgery ] [ Designated as safety issue: Yes ]
  • Vasopressor use [ Time Frame: Spinal to End Surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-spinal Headache [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Postoperative pain, wound hyperalgesia and perfusion [ Time Frame: 48 h ] [ Designated as safety issue: No ]
  • CSF and blood biochemical nociceptive and inflammatory mediators [ Time Frame: 5 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: spinal anesthesia group (SAG)
Participants will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position.
Device: Spinal Anesthesia Group (SAG)
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.
Active Comparator: The WSCG (wiley spinal catheter group)
The WSCG (wiley spinal catheter group) will undergo the standard procedures involved in placement of a spinal anesthetic in the sitting position.
Device: Wiley Spinal Catheter
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990574

Contacts
Contact: Brendan Carvalho (650) 222-7967 brendan.carvalho@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Brendan Carvalho    650-222-7967    brendan.carvalho@stanford.edu   
Principal Investigator: Brendan Carvalho         
Sub-Investigator: Philip Adam Rubin         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Brendan Carvalho Stanford University
  More Information

No publications provided

Responsible Party: Brendan Carvalho, Associate Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT00990574     History of Changes
Other Study ID Numbers: SU-10012009-4120, 17492
Study First Received: October 5, 2009
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014