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Ultrasound-Guided Landmark and Epidural Site Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813681
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Back Pain
Epidural Analgesia, Obstetric
Interventions Procedure: US-epidural SVD
Procedure: US sham- epidural SVD
Procedure: Spontaneous vaginal delivery without an Epidural
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 27 34 19
Completed 22 28 19
Not Completed 5 6 0
Reason Not Completed
Physician Decision             5             5             0
Lost to Follow-up             0             1             0
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural Total
Hide Arm/Group 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-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 - 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 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 of all reporting groups
Overall Number of Baseline Participants 22 28 19 69
Hide Baseline Analysis Population Description
The number of participants who elected to get an epidural proceed to spontaneous vaginal surgery
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 28 participants 19 participants 69 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
28
 100.0%
19
 100.0%
69
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 28 participants 19 participants 69 participants
26  (1.3) 26.3  (1.2) 26.6  (1) 26.4  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 28 participants 19 participants 69 participants
Female
22
 100.0%
28
 100.0%
19
 100.0%
69
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants 28 participants 19 participants 69 participants
22 28 19 69
body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 22 participants 28 participants 19 participants 69 participants
31.3  (1) 26.3  (1.2) 26.6  (1) 28  (1.1)
number of prior births  
Mean (Standard Deviation)
Unit of measure:  Births
Number Analyzed 22 participants 28 participants 19 participants 69 participants
2.2  (0.2) 3  (0.4) 3  (1.5) 2.7  (0.3)
length of labor  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 22 participants 28 participants 19 participants 69 participants
10.9  (1.3) 12  (1.4) 8  (0.9) 10.3  (1.5)
1.Primary Outcome
Title Epidural Pressure Sensitivity at Level of Epidural Insertion
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
pressure sensitivity at level of epidural insertion will be measured at epidural insertion site level.
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Hide Arm/Group 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-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- 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 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 Number of Participants Analyzed 22 28 19
Mean (Standard Error)
Unit of Measure: force (newtons/cm^2)
26.8  (3.2) 26.8  (2.4) 47.6  (2.3)
2.Secondary Outcome
Title Induction Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Hide Arm/Group 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-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- 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 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 Number of Participants Analyzed 22 28 19
Measure Type: Count of Participants
Unit of Measure: Participants
22 28 17
3.Secondary Outcome
Title Opioid Use During Labor
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Hide Arm/Group 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-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 - 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 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

Overall Number of Participants Analyzed 22 28 19
Measure Type: Count of Participants
Unit of Measure: Participants
6
  27.3%
9
  32.1%
9
  47.4%
4.Secondary Outcome
Title Short-term Back Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Hide Arm/Group 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-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 - 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 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

Overall Number of Participants Analyzed 22 28 19
Measure Type: Count of Participants
Unit of Measure: Participants
4
  18.2%
7
  25.0%
7
  36.8%
5.Secondary Outcome
Title Number of Needle Repositions
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD)
Hide Arm/Group 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-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 - 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.

Overall Number of Participants Analyzed 22 28
Mean (Standard Error)
Unit of Measure: number of needle repositions
0.8  (0.1) 2.2  (0.3)
6.Secondary Outcome
Title Number of Needle Insertions
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD)
Hide Arm/Group 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-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 - 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.

Overall Number of Participants Analyzed 22 28
Mean (Standard Error)
Unit of Measure: number of needle insertions
0.1  (.01) .8  (.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Hide Arm/Group Description

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.

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.

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).

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

All-Cause Mortality
US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/28 (0.00%)   0/19 (0.00%) 
Hide Serious Adverse Events
US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/28 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
US-epidural SVD (US Sham- Epidural SVD) Spontaneous Vaginal Delivery Without an Epidural
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/28 (0.00%)   0/19 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Denise Wilkes
Organization: University of Texas Medical Branch
Phone: 409-772-1221
EMail: dwilkes@utmb.edu
Layout table for additonal information
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02813681    
Other Study ID Numbers: 14-0110
First Submitted: June 16, 2016
First Posted: June 27, 2016
Results First Submitted: September 7, 2018
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019