Trial Outcomes & Findings for Ultrasound-Guided Landmark and Epidural Site Pain (NCT NCT02813681)
NCT ID: NCT02813681
Last Updated: 2019-10-03
Results Overview
pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
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.
Results posted on
2019-10-03
Participant Flow
Participant milestones
| Measure |
US-epidural SVD
Group 1: (US-epidural SVD) - 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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
Group 2: (US sham- epidural SVD) - 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
Group 5: 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).
Spontaneous vaginal delivery without an Epidural: 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
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
34
|
19
|
|
Overall Study
COMPLETED
|
22
|
28
|
19
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
0
|
Reasons for withdrawal
| Measure |
US-epidural SVD
Group 1: (US-epidural SVD) - 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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
Group 2: (US sham- epidural SVD) - 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
Group 5: 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).
Spontaneous vaginal delivery without an Epidural: 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
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
5
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
US-epidural SVD
n=22 Participants
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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
n=28 Participants
US sham- epidural SVD group - 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
n=19 Participants
Spontaneous vaginal delivery without an Epidural group 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).
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
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
28 Participants
n=28 Participants
|
19 Participants
n=19 Participants
|
69 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=69 Participants
|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 1.3 • n=22 Participants
|
26.3 years
STANDARD_DEVIATION 1.2 • n=28 Participants
|
26.6 years
STANDARD_DEVIATION 1 • n=19 Participants
|
26.4 years
STANDARD_DEVIATION 1.3 • n=69 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=22 Participants
|
28 Participants
n=28 Participants
|
19 Participants
n=19 Participants
|
69 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=22 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=69 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
28 Participants
n=28 Participants
|
19 Participants
n=19 Participants
|
69 Participants
n=69 Participants
|
|
body mass index
|
31.3 kg/m^2
STANDARD_DEVIATION 1 • n=22 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 1.2 • n=28 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 1 • n=19 Participants
|
28 kg/m^2
STANDARD_DEVIATION 1.1 • n=69 Participants
|
|
number of prior births
|
2.2 births
STANDARD_DEVIATION 0.2 • n=22 Participants
|
3 births
STANDARD_DEVIATION 0.4 • n=28 Participants
|
3 births
STANDARD_DEVIATION 1.5 • n=19 Participants
|
2.7 births
STANDARD_DEVIATION 0.3 • n=69 Participants
|
|
length of labor
|
10.9 hours
STANDARD_DEVIATION 1.3 • n=22 Participants
|
12 hours
STANDARD_DEVIATION 1.4 • n=28 Participants
|
8 hours
STANDARD_DEVIATION 0.9 • n=19 Participants
|
10.3 hours
STANDARD_DEVIATION 1.5 • n=69 Participants
|
PRIMARY outcome
Timeframe: 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.Population: pressure sensitivity at level of epidural insertion will be measured at epidural insertion site level.
pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)
Outcome measures
| Measure |
US-epidural SVD
n=22 Participants
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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
n=28 Participants
US sham- epidural SVD group- 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
n=19 Participants
Spontaneous vaginal delivery without an Epidural group 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).
Spontaneous vaginal delivery without an Epidural: 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
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
|---|---|---|---|
|
Epidural Pressure Sensitivity at Level of Epidural Insertion
|
26.8 force (newtons/cm^2)
Standard Error 3.2
|
26.8 force (newtons/cm^2)
Standard Error 2.4
|
47.6 force (newtons/cm^2)
Standard Error 2.3
|
SECONDARY outcome
Timeframe: The chart review will determine the use of induction medication immediately prior to the epidural placementThe investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)
Outcome measures
| Measure |
US-epidural SVD
n=22 Participants
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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
n=28 Participants
US sham- epidural SVD group- 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
n=19 Participants
Spontaneous vaginal delivery without an Epidural group 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).
Spontaneous vaginal delivery without an Epidural: 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
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
|---|---|---|---|
|
Induction Medication
|
22 Participants
|
28 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: A chart review of systemic opioids given to participant when the epidural is removedThe investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)
Outcome measures
| Measure |
US-epidural SVD
n=22 Participants
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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
n=28 Participants
US sham- epidural SVD group- 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
n=19 Participants
Spontaneous vaginal delivery without an Epidural group 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).
Spontaneous vaginal delivery without an Epidural: 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
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
|---|---|---|---|
|
Opioid Use During Labor
|
6 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placementThe investigator will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes answer will be recorded)
Outcome measures
| Measure |
US-epidural SVD
n=22 Participants
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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
n=28 Participants
US sham- epidural SVD group- 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
n=19 Participants
Spontaneous vaginal delivery without an Epidural group 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).
Spontaneous vaginal delivery without an Epidural: 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
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
|---|---|---|---|
|
Short-term Back Pain
|
4 Participants
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: The number of needle reposition will be counted during epidural placement.Population: The SVD without an epidural is not included in this analysis because this group did not get an epidural and therefore will not have needle repositions.
The investigator will count the number epidural needle repositions during the epidural placement (whole number)
Outcome measures
| Measure |
US-epidural SVD
n=22 Participants
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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
n=28 Participants
US sham- epidural SVD group- 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
Spontaneous vaginal delivery without an Epidural group 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).
Spontaneous vaginal delivery without an Epidural: 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
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
|---|---|---|---|
|
Number of Needle Repositions
|
0.8 number of needle repositions
Standard Error 0.1
|
2.2 number of needle repositions
Standard Error 0.3
|
—
|
SECONDARY outcome
Timeframe: The number of needle insertions will be counted during epidural placement.The investigator will count the number epidural needle insertions during the epidural placement (whole number)
Outcome measures
| Measure |
US-epidural SVD
n=22 Participants
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-epidural SVD: participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
(US Sham- Epidural SVD)
n=28 Participants
US sham- epidural SVD group- 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 participant to their group status (US epidural or US sham epidural).
US sham- epidural SVD: 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).
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
Spontaneous Vaginal Delivery Without an Epidural
Spontaneous vaginal delivery without an Epidural group 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).
Spontaneous vaginal delivery without an Epidural: 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
Algometer: Wagner FPX series manual algometer will be used to assess pain pressure threshold.
|
|---|---|---|---|
|
Number of Needle Insertions
|
0.1 number of needle insertions
Standard Error .01
|
.8 number of needle insertions
Standard Error .1
|
—
|
Adverse Events
US-epidural SVD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
(US Sham- Epidural SVD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Spontaneous Vaginal Delivery Without an Epidural
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place