Back Pain, Epidural Analgesia, Obstetric
Conditions
Keywords
Acute Pain, ultrasonography
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.
Interventions
PROCEDUREUS-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.
PROCEDUREUS 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).
PROCEDURESpontaneous 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
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epidural Pressure Sensitivity at Level of Epidural Insertion | 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. | pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Induction Medication | The chart review will determine the use of induction medication immediately prior to the epidural placement | The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded) |
| Opioid Use During Labor | A chart review of systemic opioids given to participant when the epidural is removed | The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded) |
| Short-term Back Pain | Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement | 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 number of needle reposition will be counted during epidural placement. | The investigator will count the number epidural needle repositions during the epidural placement (whole number) |
| Number of Needle Insertions | 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| (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. | 28 |
| 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 | 19 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Physician Decision | 5 | 5 | 0 |
Baseline characteristics
| Characteristic | US-epidural SVD | (US Sham- Epidural SVD) | Spontaneous Vaginal Delivery Without an Epidural | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 28 Participants | 19 Participants | 69 Participants |
| Age, Continuous | 26 years STANDARD_DEVIATION 1.3 | 26.3 years STANDARD_DEVIATION 1.2 | 26.6 years STANDARD_DEVIATION 1 | 26.4 years STANDARD_DEVIATION 1.3 |
| body mass index | 31.3 kg/m^2 STANDARD_DEVIATION 1 | 26.3 kg/m^2 STANDARD_DEVIATION 1.2 | 26.6 kg/m^2 STANDARD_DEVIATION 1 | 28 kg/m^2 STANDARD_DEVIATION 1.1 |
| length of labor | 10.9 hours STANDARD_DEVIATION 1.3 | 12 hours STANDARD_DEVIATION 1.4 | 8 hours STANDARD_DEVIATION 0.9 | 10.3 hours STANDARD_DEVIATION 1.5 |
| number of prior births | 2.2 births STANDARD_DEVIATION 0.2 | 3 births STANDARD_DEVIATION 0.4 | 3 births STANDARD_DEVIATION 1.5 | 2.7 births STANDARD_DEVIATION 0.3 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 22 Participants | 28 Participants | 19 Participants | 69 Participants |
| Sex: Female, Male Female | 22 Participants | 28 Participants | 19 Participants | 69 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 28 | 0 / 19 |
| other Total, other adverse events | 0 / 22 | 0 / 28 | 0 / 19 |
| serious Total, serious adverse events | 0 / 22 | 0 / 28 | 0 / 19 |
Outcome results
Primary
Epidural Pressure Sensitivity at Level of Epidural Insertion
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.
Population: pressure sensitivity at level of epidural insertion will be measured at epidural insertion site level.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| US-epidural SVD | Epidural Pressure Sensitivity at Level of Epidural Insertion | 26.8 force (newtons/cm^2) | Standard Error 3.2 |
| (US Sham- Epidural SVD) | Epidural Pressure Sensitivity at Level of Epidural Insertion | 26.8 force (newtons/cm^2) | Standard Error 2.4 |
| Spontaneous Vaginal Delivery Without an Epidural | Epidural Pressure Sensitivity at Level of Epidural Insertion | 47.6 force (newtons/cm^2) | Standard Error 2.3 |
Secondary
Induction Medication
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| US-epidural SVD | Induction Medication | 22 Participants |
| (US Sham- Epidural SVD) | Induction Medication | 28 Participants |
| Spontaneous Vaginal Delivery Without an Epidural | Induction Medication | 17 Participants |
Secondary
Number of Needle Insertions
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| US-epidural SVD | Number of Needle Insertions | 0.1 number of needle insertions | Standard Error 0.01 |
| (US Sham- Epidural SVD) | Number of Needle Insertions | .8 number of needle insertions | Standard Error 0.1 |
Secondary
Number of Needle Repositions
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| US-epidural SVD | Number of Needle Repositions | 0.8 number of needle repositions | Standard Error 0.1 |
| (US Sham- Epidural SVD) | Number of Needle Repositions | 2.2 number of needle repositions | Standard Error 0.3 |
Secondary
Opioid Use During Labor
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| US-epidural SVD | Opioid Use During Labor | 6 Participants |
| (US Sham- Epidural SVD) | Opioid Use During Labor | 9 Participants |
| Spontaneous Vaginal Delivery Without an Epidural | Opioid Use During Labor | 9 Participants |
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)
Time frame: Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| US-epidural SVD | Short-term Back Pain | 4 Participants |
| (US Sham- Epidural SVD) | Short-term Back Pain | 7 Participants |
| Spontaneous Vaginal Delivery Without an Epidural | Short-term Back Pain | 7 Participants |