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Clinical Trials/NCT01415232
NCT01415232
Completed
Not Applicable

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)

Manuel C. Vallejo1 site in 1 country160 target enrollmentAugust 2010
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Manuel C. Vallejo
Enrollment
160
Locations
1
Primary Endpoint
Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

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).

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
June 2011
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Manuel C. Vallejo
Responsible Party
Sponsor Investigator
Principal Investigator

Manuel C. Vallejo

Professor

University of Pittsburgh

Eligibility 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.

Outcomes

Primary Outcomes

Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)

Time Frame: at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)

Measured using the Pearson correlation coefficient between actual epidural needle depth (ND) and epidural depth as estimated by the epidural depth equation (EQ-US) followed by ultrasound (longitudinal and transverse planes) measurement.

Study Sites (1)

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