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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984267
• Other study ID #: OBUS1123
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: April 15, 2017

Study information

• Verified date: June 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 15, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Ultrasound
Using ultrasound guidance to evaluate the spine prior to epidural placement

Other:
• Palpation
Using palpation only to evaluate the spine prior to epidural placement

Locations

Country	Name	City	State
United States	Magee Women's Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas J. Vernon	West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessed immediately during epidural catheter placement
Secondary	Epidural Procedure Time	Time required to successfully place the epidural catheter	Assessed immediately during epidural catheter placement
Secondary	Number of Attempts at Epidural Catheter Placement		Assessed immediately during epidural catheter placement
Secondary	Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt		Assessed immediately during epidural catheter placement
Secondary	Complications	Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.	Assessed immediately during epidural catheter placement and within 24 hours after delivery
Secondary	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	Assessed within 24 hours after delivery
Secondary	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.	Assessed immediately following epidural catheter placement
Secondary	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.	Assessed immediately following epidural catheter placement
Secondary	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	Assessed immediately prior to epidural catheter placement
Secondary	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.	Measured within 24 hours of delivery