Clinical trial NCT03100968: Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients
Official title: Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients: A Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Anesthesia
Spinal Ultrasound
Obesity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon enrollment into the study, participants will be randomized 1:1 to either ultrasound or palpation. Randomization will be performed via random drawing: the provider will randomly select a card assigning the method of midline identification (i.e., ultrasound or palpation). Anesthesia providers will not be randomized. Any qualified provider available to place the epidural will be the person to perform the procedure.
Primary purpose: TREATMENT

Brief summary: This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural.

Detailed description: The use of ultrasound has expanded into many areas of medicine including the identification of bony landmarks to facilitate epidural placement in obstetric anesthesia. Using ultrasound for epidural placement has become popular over the last decade with several studies being published on the topic. The likely increase in popularity for ultrasound use in the obstetric population is the need to more reliably locate bony landmarks as the traditional palpation technique has been shown to be an inaccurate way to accomplish this. Given the fact that the long-taught palpation technique can be inaccurate and studies have validated the use of ultrasound for epidural placement, ultrasound technique is routinely taught by the obstetric anesthesiologists to the anesthesiology residents at the University of Alabama at Birmingham (UAB). Also, since both techniques are considered standard practice at UAB, anesthesia providers (residents, fellows, and faculty) are free to choose either technique to locate bony structures of the back prior to epidural placement. Since no current study has specifically addressed its use in the obese pregnant patient, the investigators would like to validate its use in this population.

In this study, investigators will evaluate the use of ultrasound in the obese population to determine if its use will decrease the time it takes to place the epidural and number of attempts required when compared to the traditional palpation technique. The study will also determine the success rate of epidural placement in both the palpation and ultrasound groups.

Eligibility criteria: Inclusion Criteria:

* patient request for a labor epidural
* BMI≥35

Exclusion Criteria:

* BMI\<35
* patient refusal of a labor epidural
* coagulopathy
* platelets\<80,000
* prior spine procedure or instrumentation
* a diagnosis of scoliosis
* an intracranial or spinal mass

Primary outcomes:
measure: Time for Epidural Placement
timeFrame: Baseline up to 1 hour
measure: Number of Needle Passes
timeFrame: Baseline up to 1 hour
measure: Total Time
timeFrame: Baseline up to 1 hour
Secondary outcomes:
measure: Time to Identify Midline
timeFrame: Baseline up to 1 hour
measure: Epidural Failure Rate
timeFrame: Baseline up to 1 hour
measure: Number of Top-offs Required
timeFrame: Baseline up to 1 hour
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Anesthesiology and Perioperative Medicine
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mark F Powell, MD
role: PRINCIPAL_INVESTIGATOR
References: