Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients

Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients: A Randomized, Prospective Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03100968

Enrollment

150

Registered

2017-04-04

Start date

2015-06-22

Completion date

2021-09-30

Last updated

2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Anesthesia, Spinal Ultrasound, Obesity

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.

Interventions

PROCEDUREPalpation

Traditional epidural methods used for the identification of the midline using palpation prior to procedure

DEVICEUltrasound

Lumbar spinal ultrasound performed for identification of the midline prior to procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Time for Epidural Placement	Baseline up to 1 hour	Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.
Number of Needle Passes	Baseline up to 1 hour	—
Total Time	Baseline up to 1 hour	—

Secondary

Measure	Time frame	Description
Time to Identify Midline	Baseline up to 1 hour	Comparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process.
Epidural Failure Rate	Baseline up to 1 hour	Comparing the number of epidural failures in the palpation vs. ultrasound group.
Number of Top-offs Required	Baseline up to 1 hour	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Palpation Group The palpation group will have an epidural placed after manual palpation of the spine. Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure	75
Ultrasound Group The ultrasound group will have an epidural placed after identifying midline with the ultrasound. Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.	75
Total	150

Baseline characteristics

Characteristic	Ultrasound Group	Total	Palpation Group
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	75 Participants	150 Participants	75 Participants
Body Mass Index	43.3 kg/m^2 STANDARD_DEVIATION 7.1	43.8 kg/m^2 STANDARD_DEVIATION 7	44.4 kg/m^2 STANDARD_DEVIATION 6.9
Height	164.2 Centimeters STANDARD_DEVIATION 7.1	164.1 Centimeters STANDARD_DEVIATION 7.7	163.9 Centimeters STANDARD_DEVIATION 8.2
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	75 participants	150 participants	75 participants
Sex: Female, Male Female	75 Participants	150 Participants	75 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Weight	116.8 Kilograms STANDARD_DEVIATION 20.2	118.1 Kilograms STANDARD_DEVIATION 20.4	119.5 Kilograms STANDARD_DEVIATION 20.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 75	0 / 75
other Total, other adverse events	0 / 75	0 / 75
serious Total, serious adverse events	0 / 75	0 / 75