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| Name | Class |
|---|---|
| West Penn Allegheny Health System | OTHER |
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Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Group | Experimental | The interventional group that will have their spine evaluated by ultrasound prior to epidural placement |
|
| Palpation Group | Other | The control group that will have their epidural placed in the usual fashion based on palpation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Using ultrasound guidance to evaluate the spine prior to epidural placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Time Required for Epidural Catheter Placement | Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter | Assessed immediately during epidural catheter placement |
| Measure | Description | Time Frame |
|---|---|---|
| Epidural Procedure Time | Time required to successfully place the epidural catheter | Assessed immediately during epidural catheter placement |
| Number of Attempts at Epidural Catheter Placement | Assessed immediately during epidural catheter placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Women's Hospital | Pittsburgh | Pennsylvania | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Group | The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement |
| FG001 | Palpation Group | The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Ultrasound 43.75% (7/16); Palpation 56.25% (9/16)
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound Group | The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement |
| BG001 | Palpation Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Total Time Required for Epidural Catheter Placement | Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter | Posted | Mean | Standard Deviation | Minutes | Assessed immediately during epidural catheter placement |
|
During the patients current hospitalization (typically 2-3 days)
All study participants were evaluated during and immediately following their epidural catheter procedure, and also later followed up on in person by study personnel within 24 hours of their delivery to assess for any adverse events
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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 | Ultrasound Group | The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inadvertent dural puncture | Injury, poisoning and procedural complications | Systematic Assessment | Number of participants sustaining an inadvertent dural puncture during the procedure resulting in the formation of a post-dural puncture headache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Vernon | Arizona Anesthesia Consultants | 480-570-7082 | tvernon@azanesthesia.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2016 | May 7, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 1, 2016 | May 7, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Palpation | Other | Using palpation only to evaluate the spine prior to epidural placement |
|
| Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt | Assessed immediately during epidural catheter placement |
| Complications | Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported. | Assessed immediately during epidural catheter placement and within 24 hours after delivery |
| Epidural Failure Rate | Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported | Assessed within 24 hours after delivery |
| Epidural Catheter Placement Satisfaction Level | Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied. | Assessed immediately following epidural catheter placement |
| Patient Anxiety Level | Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable. | Assessed immediately following epidural catheter placement |
| Palpation or Ultrasound Time | The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion | Assessed immediately prior to epidural catheter placement |
| Overall Anesthesia Experience Satisfaction | Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used. | Measured within 24 hours of delivery |
The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gravidity | Median | Inter-Quartile Range | Number of pregnancies |
|
| Parity | Median | Inter-Quartile Range | Number of children born |
|
| Estimated gestational age | Mean | Standard Deviation | Weeks |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologists (ASA) physical status | ASA1, ASA2, and ASA3 are all categories that participants could fall into based on the status of their overall health. ASA1 indicates a normal, healthy patient. ASA2 indicates a patient with mild systemic disease (examples include but are not limited to pregnancy, current smoker, obesity with a BMI >30 but <40, and well controlled diabetes or hypertension). ASA3 indicates a patient with severe systemic disease (examples include but are not limited to poorly controlled diabetes or hypertension, chronic obstructive pulmonary disorder, morbid obesity with a BMI greater than or equal to 40). | Count of Participants | Participants |
|
| External landmarks visible | The back of the patient is visually examined to determine if the outline of the spinous processes of the vertebrae can be seen through the skin. | Count of Participants | Participants |
|
| Palpable interspace | A patient has "palpable interspaces" when the spinous processes of the vertebrae, and thus the interspaces between them, can easily be physically felt by the provider through the patient's skin. | Palpation was not performed in ultrasound group because only the ultrasound was used to asses location for epidural catheter placement in that group. The number of participants in the ultrasound group reflects only the number analyzed (i.e. 0) and the total number of participants analyzed reflects the total number analyzed (i.e. 9 participants). | Count of Participants | Participants |
|
|
|
| Secondary | Epidural Procedure Time | Time required to successfully place the epidural catheter | Posted | Mean | Standard Deviation | Minutes | Assessed immediately during epidural catheter placement |
|
|
|
| Secondary | Number of Attempts at Epidural Catheter Placement | Posted | Median | Inter-Quartile Range | Number of attempts | Assessed immediately during epidural catheter placement |
|
|
|
| Secondary | Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt | Posted | Count of Participants | Participants | Assessed immediately during epidural catheter placement |
|
|
|
| Secondary | Complications | Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported. | Posted | Number | Complications | Assessed immediately during epidural catheter placement and within 24 hours after delivery |
|
|
|
| Secondary | Epidural Failure Rate | Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported | Posted | Count of Participants | Participants | Assessed within 24 hours after delivery |
|
|
|
| Secondary | Epidural Catheter Placement Satisfaction Level | Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied. | Posted | Mean | Standard Deviation | Units on a scale | Assessed immediately following epidural catheter placement |
|
|
|
| Secondary | Patient Anxiety Level | Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable. | Posted | Mean | Standard Deviation | Units on a scale | Assessed immediately following epidural catheter placement |
|
|
|
| Secondary | Palpation or Ultrasound Time | The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion | Posted | Mean | Standard Deviation | Minutes | Assessed immediately prior to epidural catheter placement |
|
|
|
| Secondary | Overall Anesthesia Experience Satisfaction | Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used. | Posted | Mean | Standard Deviation | Units on a scale | Measured within 24 hours of delivery |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Palpation Group | The control group that will have their epidural placed in the usual fashion based on palpation Palpation: Using palpation only to evaluate the spine prior to epidural placement | 0 | 9 | 0 | 9 | 3 | 9 |
|
| Paresthesia | Injury, poisoning and procedural complications | Systematic Assessment | Number of patients experiencing a transient paresthesia in their back or leg(s) during epidural catheter placement |
|
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ASA3 |
|