A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

NCT ID: NCT01415232

Last Updated: 2017-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-06-30

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).

Conditions

Obesity

Keywords

Obesity; Ultrasound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ultrasound measurement

Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Other Intervention Names

Ultrasound machine; Sonosite

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Manuel C. Vallejo

OTHER

Sponsor Role: lead

Responsible Party

Manuel C. Vallejo

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Manuel C. Vallejo, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO10070214

Identifier Type: -

Identifier Source: org_study_id