Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40

• Sponsor: Thomas J. Vernon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02984267
• Collaborator: West Penn Allegheny Health System (Other)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 4.4
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Device: Ultrasound; Other: Palpation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Apr 15, 2017
• Actual Study Completion Date: Apr 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound Group The interventional group that will have their spine evaluated by ultrasound prior to epidural placement	Device: Ultrasound; Using ultrasound guidance to evaluate the spine prior to epidural placement
Other: Palpation Group The control group that will have their epidural placed in the usual fashion based on palpation	Other: Palpation; Using palpation only to evaluate the spine prior to epidural placement

Outcome Measures

Primary Outcome Measures

1. Total Time Required for Epidural Catheter Placement [Assessed immediately during epidural catheter placement]

   Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter

Secondary Outcome Measures

1. Epidural Procedure Time [Assessed immediately during epidural catheter placement]

   Time required to successfully place the epidural catheter

2. Number of Attempts at Epidural Catheter Placement [Assessed immediately during epidural catheter placement]

3. Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt [Assessed immediately during epidural catheter placement]

4. Complications [Assessed immediately during epidural catheter placement and within 24 hours after delivery]

   Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.

5. Epidural Failure Rate [Assessed within 24 hours after delivery]

   Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported

6. Epidural Catheter Placement Satisfaction Level [Assessed immediately following epidural catheter placement]

   Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.

7. Patient Anxiety Level [Assessed immediately following epidural catheter placement]

   Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.

8. Palpation or Ultrasound Time [Assessed immediately prior to epidural catheter placement]

   The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion

9. Overall Anesthesia Experience Satisfaction [Measured within 24 hours of delivery]

   Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Current (pregnant) BMI ≥ 40

• Age ≥ 18

• ASA score of 3 or less

• Full term pregnancy (37 weeks gestational age or greater)

Exclusion Criteria:

• Known scoliosis

• Known contraindications to neuraxial blockade

• Intrauterine fetal demise or non-viable fetus.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee Women's Hospital	Pittsburgh	Pennsylvania	United States

Sponsors and Collaborators

• Thomas J. Vernon
• West Penn Allegheny Health System

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - Oct 1, 2016
• Study Protocol - Oct 1, 2016

More Information

Publications

None provided.

• Responsible Party: Thomas J. Vernon, OB Anesthesia Fellow, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02984267
• Other Study ID Numbers: OBUS1123
• First Posted: Dec 6, 2016
• Last Update Posted: Jul 11, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Labor Pain

Study Results

Participant Flow

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Period Title: Overall Study
STARTED	8	10
COMPLETED	7	9
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Ultrasound Group	Palpation Group	Total
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement	Total of all reporting groups
Overall Participants	7	9	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.3 (4.7)	29.9 (5.5)	27.9 (5.4)
Sex: Female, Male (Count of Participants)
Female	7 100%	9 100%	16 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 14.3%	1 11.1%	2 12.5%
White	6 85.7%	8 88.9%	14 87.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Gravidity (Number of pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Number of pregnancies]	1	2	2
Parity (Number of children born) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Number of children born]	0	0	0
Estimated gestational age (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	39.6 (0.8)	38.1 (1.1)	38.7 (1.1)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	122.0 (17.1)	120.6 (15.8)	121.2 (15.8)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	163.7 (5.3)	162.1 (5.3)	162.8 (5.2)
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	45.6 (7.4)	45.9 (6.3)	45.8 (6.6)
American Society of Anesthesiologists (ASA) physical status (Count of Participants)
ASA1	0 0%	0 0%	0 0%
ASA2	0 0%	0 0%	0 0%
ASA3	7 100%	9 100%	16 100%
External landmarks visible (Count of Participants)
Yes	0 0%	0 0%	0 0%
No	7 100%	9 100%	16 100%
Palpable interspace (Count of Participants)
Yes	0 0%	5 55.6%	5 31.3%
No	0 0%	4 44.4%	4 25%

Outcome Measures

1. Primary Outcome

Title	Total Time Required for Epidural Catheter Placement
Description	Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
Time Frame	Assessed immediately during epidural catheter placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Mean (Standard Deviation) [Minutes]	6.1 (3.5)	11.0 (5.3)

2. Secondary Outcome

Title	Epidural Procedure Time
Description	Time required to successfully place the epidural catheter
Time Frame	Assessed immediately during epidural catheter placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Mean (Standard Deviation) [Minutes]	4.33 (3.5)	10.1 (5.4)

3. Secondary Outcome

Title	Number of Attempts at Epidural Catheter Placement
Time Frame	Assessed immediately during epidural catheter placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Median (Inter-Quartile Range) [Number of attempts]	1	5

4. Secondary Outcome

Title	Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
Time Frame	Assessed immediately during epidural catheter placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Count of Participants [Participants]	5 71.4%	2 22.2%

5. Secondary Outcome

Title	Complications
Description	Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.
Time Frame	Assessed immediately during epidural catheter placement and within 24 hours after delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Number [Complications]	0	4

6. Secondary Outcome

Title	Epidural Failure Rate
Description	Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported
Time Frame	Assessed within 24 hours after delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Epidural Catheter Placement Satisfaction Level
Description	Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.
Time Frame	Assessed immediately following epidural catheter placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Mean (Standard Deviation) [Units on a scale]	9 (1.2)	7.3 (2.8)

8. Secondary Outcome

Title	Patient Anxiety Level
Description	Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.
Time Frame	Assessed immediately following epidural catheter placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Mean (Standard Deviation) [Units on a scale]	5.4 (1.9)	6.0 (2.6)

9. Secondary Outcome

Title	Palpation or Ultrasound Time
Description	The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion
Time Frame	Assessed immediately prior to epidural catheter placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Mean (Standard Deviation) [Minutes]	1.8 (0.6)	0.9 (0.1)

10. Secondary Outcome

Title	Overall Anesthesia Experience Satisfaction
Description	Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.
Time Frame	Measured within 24 hours of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasound Group	Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement	The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
Measure Participants	7	9
Mean (Standard Deviation) [Units on a scale]	79.1 (11.8)	74.3 (9.4)

Adverse Events

Time Frame	During the patients current hospitalization (typically 2-3 days)
Adverse Event Reporting Description	All study participants were evaluated during and immediately following their epidural catheter procedure, and also later followed up on in person by study personnel within 24 hours of their delivery to assess for any adverse events
Arm/Group Title	Ultrasound Group		Palpation Group
Arm/Group Description	The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement		The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement
All Cause Mortality
	Ultrasound Group		Palpation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/9 (0%)
Serious Adverse Events
	Ultrasound Group		Palpation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Ultrasound Group		Palpation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		3/9 (33.3%)
Injury, poisoning and procedural complications
Inadvertent dural puncture	0/7 (0%)	0	1/9 (11.1%)	1
Paresthesia	0/7 (0%)	0	2/9 (22.2%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.