Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Palpation
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain
Eligibility Criteria
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.
Sites / Locations
- Magee Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Ultrasound Group
Palpation Group
Arm Description
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
The control group that will have their epidural placed in the usual fashion based on palpation
Outcomes
Primary Outcome Measures
Total Time Required for 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
Epidural Procedure Time
Time required to successfully place the epidural catheter
Number of Attempts at Epidural Catheter Placement
Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
Complications
Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.
Epidural Failure Rate
Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported
Epidural Catheter Placement Satisfaction Level
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.
Patient Anxiety Level
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.
Palpation or Ultrasound Time
The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion
Overall Anesthesia Experience Satisfaction
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.
Full Information
NCT ID
NCT02984267
First Posted
November 23, 2016
Last Updated
June 13, 2018
Sponsor
Thomas J. Vernon
Collaborators
West Penn Allegheny Health System
1. Study Identification
Unique Protocol Identification Number
NCT02984267
Brief Title
Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
Official Title
Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
April 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas J. Vernon
Collaborators
West Penn Allegheny Health System
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Group
Arm Type
Experimental
Arm Description
The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Arm Title
Palpation Group
Arm Type
Other
Arm Description
The control group that will have their epidural placed in the usual fashion based on palpation
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Using ultrasound guidance to evaluate the spine prior to epidural placement
Intervention Type
Other
Intervention Name(s)
Palpation
Intervention Description
Using palpation only to evaluate the spine prior to epidural placement
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Epidural Procedure Time
Description
Time required to successfully place the epidural catheter
Time Frame
Assessed immediately during epidural catheter placement
Title
Number of Attempts at Epidural Catheter Placement
Time Frame
Assessed immediately during epidural catheter placement
Title
Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
Time Frame
Assessed immediately during epidural catheter placement
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
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
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
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
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
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Magee Women's Hospital
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
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Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
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