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A Study Comparing Two Spinal Techniques for for Cesarean Delivery Anesthesia

NCT00990574 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-10-08

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Brendan Carvalho · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990574 on ClinicalTrials.gov