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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US-epidural SVD | Active Comparator | 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) | Sham Comparator | US sham- epidural SVD group- participants who received US examination process but with the monitor turned off. |
|
| SVD without an Epidural | Placebo Comparator | Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| US-epidural SVD | Procedure | participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity. |
| Measure | Description | Time Frame |
|---|---|---|
| Epidural Pressure Sensitivity at Level of Epidural Insertion | pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Induction Medication | The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded) | The chart review will determine the use of induction medication immediately prior to the epidural placement |
| Opioid Use During Labor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Wilkes | UTMB | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | (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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The number of participants who elected to get an epidural proceed to spontaneous vaginal surgery
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| ID | Title | Description |
|---|---|---|
| BG000 | US-epidural SVD | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Epidural Pressure Sensitivity at Level of Epidural Insertion | pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons) | pressure sensitivity at level of epidural insertion will be measured at epidural insertion site level. | Posted | Mean | Standard Error | force (newtons/cm^2) | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Wilkes | University of Texas Medical Branch | 409-772-1221 | dwilkes@utmb.edu |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| US sham- epidural SVD | Procedure | 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). |
|
| Spontaneous vaginal delivery without an Epidural | Procedure | 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 |
|
The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded) |
| A chart review of systemic opioids given to participant when the epidural is removed |
| 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) | Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement |
| Number of Needle Repositions | The investigator will count the number epidural needle repositions during the epidural placement (whole number) | The number of needle reposition will be counted during epidural placement. |
| Number of Needle Insertions | The investigator will count the number epidural needle insertions during the epidural placement (whole number) | The number of needle insertions will be counted during epidural placement. |
| BG001 | (US Sham- Epidural SVD) | 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. |
| BG002 | 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). 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| body mass index | Mean | Standard Deviation | kg/m^2 |
|
| number of prior births | Mean | Standard Deviation | births |
|
| length of labor | Mean | Standard Deviation | hours |
|
| OG001 | (US Sham- Epidural SVD) | 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. |
| OG002 | 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. |
|
|
| Secondary | Induction Medication | The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded) | Posted | Count of Participants | Participants | No | The chart review will determine the use of induction medication immediately prior to the epidural placement |
|
|
|
| Secondary | Opioid Use During Labor | The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded) | Posted | Count of Participants | Participants | A chart review of systemic opioids given to participant when the epidural is removed |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement |
|
|
|
| Secondary | Number of Needle Repositions | The investigator will count the number epidural needle repositions during the epidural placement (whole number) | 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. | Posted | Mean | Standard Error | number of needle repositions | The number of needle reposition will be counted during epidural placement. |
|
|
|
| Secondary | Number of Needle Insertions | The investigator will count the number epidural needle insertions during the epidural placement (whole number) | Posted | Mean | Standard Error | number of needle insertions | The number of needle insertions will be counted during epidural placement. |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | (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. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | 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). 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 | 0 | 19 | 0 | 19 | 0 | 19 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|