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Completed

NCT Number: NCT01415232

A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

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.

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Key information

Age range

14 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sonosite S-Nerve® US system (SonoSite, Bothell,WA)

Device

Ultrasound to measure depth to the epidural space in morbidly obese parturients

Other names: Ultrasound machine, Sonosite

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Manuel C. Vallejo

Other

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2011
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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