A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01415232
First received: August 9, 2011
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine the correlation between actual epidural needle depth (ND) and the use of ultrasound with an epidural depth equation (EQ-US) to estimate epidural depth (Est-D) in morbidly obese parturients. It is well documented that in women with a BMI greater than 40 kg/m2 successful epidural placement is more difficult. To the best of our knowledge the use of an epidural depth equation, which was developed in an earlier study using height and weight, with ultrasound visualization will improve identification of the epidural space.


Condition Intervention
Obesity
Device: Sonosite S-Nerve® US system (SonoSite, Bothell,WA)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of Ultrasound With the Epidural Depth Equation (EQ-US) to Estimate Epidural Depth (Est-D) in Morbidly Obese Parturients (BMI>40Kg/m2) Will Have a High Correlation With Actual Epidural Needle Depth (ND)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Estimate Epidural Depth in Morbidly Obese Parturients (BMI>40kg/m2) [ Time Frame: Five minutes for ultrasound measurement ] [ Designated as safety issue: No ]
    To determine the correlation between actual epidural needle depth (ND) and estimated epidural depth (Est-D) with the use of ultrasound and the epidural depth equation (EQ-US).

  • Epidural Depth [ Time Frame: at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization) ] [ Designated as safety issue: No ]
    epidural depth measured from the skin to the epidural space with the use of ultrasound done just prior to labor epidural catheter insertion for relief of labor pain.


Enrollment: 160
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound measurement
Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
Device: Sonosite S-Nerve® US system (SonoSite, Bothell,WA)
Ultrasound to measure depth to the epidural space in morbidly obese parturients
Other Names:
  • Ultrasound machine
  • Sonosite

Detailed Description:

The investigators plan to enroll women who are morbidly obese (BMI > 40 kg/m2) and request epidural analgesia for labor. After written informed consent, 160 patients will have the use of the epidural depth equation with ultrasound (EQ-US) to estimate epidural depth (Est-D). US visualization of the epidural space will be completed by the principle investigator who has had extensive training in epidural US visualization. The EQ-US depth will be recorded. After US use, another provider who is listed as an investigator will place the epidural catheter without prior knowledge of the estimated epidural depth with the use of the equation and US. The actual needle depth to the epidural space (ND) will be recorded.

Data collected from the patient's medical record will include demographic data (age, height, weight) gravidity, parity, and cervical dilation. Measured variables will include the estimated epidural depth (Est-D) as measured by the epidural depth equation with the use of ultrasound (EQ-US), and actual epidural needle depth (ND). The investigators believe that the use of ultrasound with the epidural depth equation (EQ-US) to estimate epidural depth (Est-D) in morbidly obese parturients will have a high correlation with actual epidural needle depth (ND).

  Eligibility

Ages Eligible for Study:   14 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All women of childbearing age (including children aged 14 years and above) with a BMI > 40kg/m2 who request epidural analgesia at Magee-Womens Hospital will be eligible to participate in the study. Men will not be included since they can not become pregnant. All patients will be recruited at Magee-Womens Hospital.

Exclusion Criteria:

Patients with severe preeclampsia will be excluded from the study, as these patients may have significant edema which could alter ultrasound and/or epidural needle depth measurement. Patients with a history of back surgery, significant scoliosis, and/or lumbar pathology (i.e. Ankylosing Spondylitis) will be excluded from the study because these conditions could complicate ultrasound visualization and/or epidural needle placement.

  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: NCT01415232

Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Manuel C. Vallejo, M.D. Magee Womens Hospital of UPMC
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01415232     History of Changes
Other Study ID Numbers: PRO10070214
Study First Received: August 9, 2011
Results First Received: February 1, 2013
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Obesity
Ultrasound

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014