How Sweet is it? Measurement of Glucose in Epidural and Spinal Fluid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01391702
First received: July 6, 2011
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

When a woman requires a cesarean section after labour, anesthesia is usually provided by a pre-existing epidural. Occasionally, the epidural does not work. The anesthesiologist then may give a "spinal anesthetic". The spinal space is identified by seeing cerebrospinal fluid (CSF) in the spinal needle. Rarely a spinal fails after a failed epidural as the fluid seen is epidural space fluid, not CSF. This study plans to use a bedside glucose monitor to measure glucose (sugar) in epidural fluid (compared to CSF) allowing the anesthesiologist to know the spinal needle is in the correct space.

The investigators hypothesize that a bedside glucose measurement device can accurately quantitate the level of glucose within epidural space aspirate, and therefore could aid differentiation between CSF and epidural fluid.


Condition
Epidural and Spinal Anesthesia for Cesarean Delivery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Sweet is it? Measurement of Glucose in Epidural Fluid and Fluid Obtained During Spinal Anesthesia After a Failed Epidural Using a Bedside Monitor

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • To confirm that the glucose meter is a feasible and accurate bedside method to detect glucose in epidural aspirate and to use glucose to differentiate CSF from epidural aspirate in women with pre-existing epidural catheters. [ Time Frame: Between 2-24 hours after labouring woman has an epidural placed for her labour ] [ Designated as safety issue: No ]
    Descriptive statistics outlining the range, central tendency (mean, median), and variability (standard deviation) for epidural glucose will be presented, and these figures then compared to those obtained from the Sweet CSF study.


Secondary Outcome Measures:
  • Influence of other factors on epidural glucose [ Time Frame: Between 2-24 hours after labouring woman has an epidural placed for her labour ] [ Designated as safety issue: No ]

    Paired t-tests will be conducted to compare epidural glucose levels, blood glucose levels and the influence of the following on the glucose concentration within the epidural aspirate:

    1. Glucose ingestion
    2. Intravenous administration of glucose containing fluids
    3. Disorders of glucose metabolism
    4. Length of time that the epidural catheter was in situ


Enrollment: 65
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Labouring woman with epidural in situ
Any healthy English-speaking pregnant woman in labour who has received an epidural for pain relief

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy pregnant women who are admitted to the hospital in labour who receive an epidural for pain relief

Criteria

Inclusion Criteria:

  • Healthy women (American Society of Anesthesiologists (ASA) 1 or 2 classification) with a pre-existing epidural. This will include women with uncomplicated disorders of glucose metabolism e.g. gestational diabetes, insulin dependent gestational diabetes and insulin dependent diabetes.
  • Singleton pregnancy
  • Age 19 years or older
  • Understand written and oral English

Exclusion Criteria:

• Emergency cesarean delivery where time would not allow full consent or sampling

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01391702

Locations
Canada, British Columbia
British Columbia's Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Giselle Villar, MD, FRCPA University of British Columbia, BC Women's Hospital
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01391702     History of Changes
Other Study ID Numbers: H11-00901
Study First Received: July 6, 2011
Last Updated: April 5, 2012
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on July 23, 2014