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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03100968
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 74.3
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epidural Anesthesia; Spinal Ultrasound; Obesity	Procedure: Palpation; Device: Ultrasound	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients: A Randomized, Prospective Study
• Actual Study Start Date: Jun 22, 2015
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Palpation Group The palpation group will have an epidural placed after manual palpation of the spine.	Procedure: Palpation; Traditional epidural methods used for the identification of the midline using palpation prior to procedure
Active Comparator: Ultrasound Group The ultrasound group will have an epidural placed after identifying midline with the ultrasound.	Device: Ultrasound; Lumbar spinal ultrasound performed for identification of the midline prior to procedure.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Number of Needle Passes [Baseline up to 1 hour]

3. Total Time [Baseline up to 1 hour]

Secondary Outcome Measures

1. 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.

2. Epidural Failure Rate [Baseline up to 1 hour]

   Comparing the number of epidural failures in the palpation vs. ultrasound group.

3. Number of Top-offs Required [Baseline up to 1 hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Department of Anesthesiology and Perioperative Medicine	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Mark F Powell, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2015

More Information

Publications

None provided.

• Responsible Party: Mark Powell, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03100968
• Other Study ID Numbers: F150402002
• First Posted: Apr 4, 2017
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Arm/Group Title	Palpation Group	Ultrasound Group
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	75	75
COMPLETED	75	75
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Palpation Group	Ultrasound Group	Total
Arm/Group Description	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	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.	Total of all reporting groups
Overall Participants	75	75	150
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	75 100%	75 100%	150 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	75 100%	75 100%	150 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	75 100%	75 100%	150 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	44.4 (6.9)	43.3 (7.1)	43.8 (7.0)
Height (Centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimeters]	163.9 (8.2)	164.2 (7.1)	164.1 (7.7)
Weight (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]	119.5 (20.6)	116.8 (20.2)	118.1 (20.4)

Outcome Measures

1. Primary Outcome

Title	Time for Epidural Placement
Description	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.
Time Frame	Baseline up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation Group	Ultrasound Group
Arm/Group Description	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	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.
Measure Participants	75	75
Mean (Standard Deviation) [minutes]	9.0 (6.8)	6.2 (3.8)

2. Primary Outcome

Title	Number of Needle Passes
Time Frame	Baseline up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation Group	Ultrasound Group
Arm/Group Description	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	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.
Measure Participants	75	75
Mean (Standard Deviation) [needle passes]	2.8 (2.0)	2.1 (1.4)

3. Primary Outcome

Title	Total Time
Time Frame	Baseline up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation Group	Ultrasound Group
Arm/Group Description	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	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.
Measure Participants	75	75
Mean (Standard Deviation) [Minutes]	9.5 (6.8)	6.9 (3.9)

4. Secondary Outcome

Title	Time to Identify Midline
Description	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.
Time Frame	Baseline up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation Group	Ultrasound Group
Arm/Group Description	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	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.
Measure Participants	75	75
Mean (Standard Deviation) [seconds]	30.9 (16.3)	44.5 (24.7)

5. Secondary Outcome

Title	Epidural Failure Rate
Description	Comparing the number of epidural failures in the palpation vs. ultrasound group.
Time Frame	Baseline up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation Group	Ultrasound Group
Arm/Group Description	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	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.
Measure Participants	75	75
Number [failed epidurals]	7	3

6. Secondary Outcome

Title	Number of Top-offs Required
Time Frame	Baseline up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation Group	Ultrasound Group
Arm/Group Description	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	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.
Measure Participants	75	75
Mean (Standard Deviation) [number of topoffs required]	0.5 (1.1)	0.4 (0.9)

Adverse Events

Time Frame	Baseline up to 1 hour
Arm/Group Title	Palpation Group		Ultrasound Group
Arm/Group Description	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		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.
All Cause Mortality
	Palpation Group		Ultrasound Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Serious Adverse Events
	Palpation Group		Ultrasound Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Palpation Group		Ultrasound Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.