N/A N=160 Diagnostic

A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01415232 ↗

Enrolled (actual)

160

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D) — 0.905; 0.899 correlation coefficient — p=< 0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sonosite S-Nerve® US system (SonoSite, Bothell,WA) (Device)
Age: Pediatric, Adult · 14+ yrs
Sex: Female
Sponsor: Manuel C. Vallejo
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)	0.905; 0.899	< 0.05 sig

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01415232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.