Ultrasound-Guided Landmark and Epidural Site Pain
Primary Purpose
Back Pain, Epidural Analgesia, Obstetric
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
US-epidural SVD
US sham- epidural SVD
Spontaneous vaginal delivery without an Epidural
Sponsored by
About this trial
This is an interventional prevention trial for Back Pain focused on measuring Acute Pain, ultrasonography
Eligibility Criteria
Inclusion Criteria:
- pregnant with term (37 - 41 weeks) singleton gestation
- active labor
- history of normal pregnancy
- request an epidural
- age between 18 - 35 years old
- able to understand the protocol and provide voluntary, written, informed consent.
Exclusion Criteria:
- history of spinal surgery
- scoliosis
- epidural or spinal placement within the last 5 days
- neuropathic pain disorders
- chronic opioid use
- Texas Department of Criminal Justice patient
- placental percreta
- placental increta
- placenta accreta
- preeclampsia
- eclampsia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
Placebo Comparator
Arm Label
US-epidural SVD
(US sham- epidural SVD)
SVD without an Epidural
Arm Description
US-epidural SVD group - participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity
US sham- epidural SVD group- participants who received US examination process but with the monitor turned off.
Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline.
Outcomes
Primary Outcome Measures
Epidural Pressure Sensitivity at Level of Epidural Insertion
pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)
Secondary Outcome Measures
Induction Medication
The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)
Opioid Use During Labor
The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)
Short-term Back Pain
The investigator will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes answer will be recorded)
Number of Needle Repositions
The investigator will count the number epidural needle repositions during the epidural placement (whole number)
Number of Needle Insertions
The investigator will count the number epidural needle insertions during the epidural placement (whole number)
Full Information
NCT ID
NCT02813681
First Posted
June 16, 2016
Last Updated
October 2, 2019
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT02813681
Brief Title
Ultrasound-Guided Landmark and Epidural Site Pain
Official Title
A Prospective Randomized Clinical Trial to Study the Effect of Pre-Epidural Ultrasound Examination on Epidural Insertion Site Pressure Sensitivity in Parturient
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Historically, women who have chronic back pain after pregnancy have attributed the cause to the epidural procedure. While many studies have shown no greater incidence of generalized post-partum back pain in those who received an epidural, no studies have measured localized pressure sensitivity at the epidural insertion site. Short-term pressure sensitivity might limit patient's mobility and activities in the post-partum period. Understanding the factors that increase insertion site pressure sensitivity will allow the investigators to modify epidural placement technique in order to minimize this effect.
Detailed Description
Few studies have examined how epidural placement changes localized sensation at the epidural insertion site. This study will be the first study to quantitatively measure sensation at the epidural insertion site. The investigator will assess localized pressure sensitivity with an algometer. An algometer is a hand-held device commonly used by neurologist to detect sensory deficits and measures the pressure sensitivity threshold in a 1-cm diameter circular area. Ultrasound (US) pre-procedural examination provides more accurate landmarks for the placement of epidural catheters. The investigator will determine if an US examination prior to epidural placement reduces localized pressure sensitivity. The investigator will also determine if there are correlations between the participants characteristics and/or comorbidities and increased pressure sensitivity at the insertion site.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Epidural Analgesia, Obstetric
Keywords
Acute Pain, ultrasonography
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
US-epidural SVD
Arm Type
Active Comparator
Arm Description
US-epidural SVD group - participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity
Arm Title
(US sham- epidural SVD)
Arm Type
Sham Comparator
Arm Description
US sham- epidural SVD group- participants who received US examination process but with the monitor turned off.
Arm Title
SVD without an Epidural
Arm Type
Placebo Comparator
Arm Description
Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline.
Intervention Type
Procedure
Intervention Name(s)
US-epidural SVD
Intervention Description
participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Intervention Type
Procedure
Intervention Name(s)
US sham- epidural SVD
Intervention Description
participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the patient to their group status (US epidural or US sham epidural).
Intervention Type
Procedure
Intervention Name(s)
Spontaneous vaginal delivery without an Epidural
Intervention Description
Spontaneous vaginal delivery without an Epidural The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural). This information will tell the investigator how many women have back pain after spontaneous vaginal delivery. Participant must meet the inclusion requirements and not meet any of the exclusion requirements
Primary Outcome Measure Information:
Title
Epidural Pressure Sensitivity at Level of Epidural Insertion
Description
pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)
Time Frame
Epidural pressure sensitivity was monitored 10 minutes prior to epidural insertion and then for 10 minutes on each day after epidural removal for 3 days.
Secondary Outcome Measure Information:
Title
Induction Medication
Description
The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)
Time Frame
The chart review will determine the use of induction medication immediately prior to the epidural placement
Title
Opioid Use During Labor
Description
The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)
Time Frame
A chart review of systemic opioids given to participant when the epidural is removed
Title
Short-term Back Pain
Description
The investigator will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes answer will be recorded)
Time Frame
Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement
Title
Number of Needle Repositions
Description
The investigator will count the number epidural needle repositions during the epidural placement (whole number)
Time Frame
The number of needle reposition will be counted during epidural placement.
Title
Number of Needle Insertions
Description
The investigator will count the number epidural needle insertions during the epidural placement (whole number)
Time Frame
The number of needle insertions will be counted during epidural placement.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant with term (37 - 41 weeks) singleton gestation
active labor
history of normal pregnancy
request an epidural
age between 18 - 35 years old
able to understand the protocol and provide voluntary, written, informed consent.
Exclusion Criteria:
history of spinal surgery
scoliosis
epidural or spinal placement within the last 5 days
neuropathic pain disorders
chronic opioid use
Texas Department of Criminal Justice patient
placental percreta
placental increta
placenta accreta
preeclampsia
eclampsia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Wilkes
Organizational Affiliation
UTMB
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound-Guided Landmark and Epidural Site Pain
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