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The investigators believe that ultrasound guided CSE technique will help junior resident rotating for the first time on the labor and delivery floor to place more accurately the epidural needle in the midline position as compared to placing the epidural needle via palpation of anatomical landmarks. This will result in increased ability to place the spinal component with positive cerebral spinal fluid (CSF) in the spinal needle, correct midline placement of the epidural catheter, and increase the likelihood of adequate symmetrical labor analgesia/anesthesia.
Epidurals provide superior labor analgesia and anesthesia. Unfortunately, failure of epidural anesthesia and analgesia is a frequent clinical problem. In a heterogeneous cohort of 2,140 surgical patients, a failure rate of 27% for lumbar epidural was described. However, the definition of a failed epidural is broad. Different definitions include insufficient analgesia to catheter dislodgement to conversion to general anesthesia. Epidural analgesia failures may result from technical difficulties, insufficiencies or overdosing of local anesthetics, epidural septum or midline adhesions, and placement of the epidural catheter through an intervertebral foramen or into the anterior epidural space. In an imaging study of failed epidurals, incorrect catheter placement accounted for half of the failures, while the remaining patients experienced suboptimal analgesia through a correctly positioned catheter.
The incidence of overall failure was lower in patients receiving combined spinal-epidural (CSE) catheters versus epidural analgesia. In one study, the CSE technique provided decreased failure rates for labor analgesia and comparable or decreased failure rates for surgical anesthesia, when compared with reported failure rates for epidural anesthesia. It is believed that positive CSF flow in the spinal needle confirms correct epidural needle placement in the epidural space and also confirms the epidural needle to be in the midline position. Placement of the epidural needle in the midline position will minimize the incorrect placement of the catheter to one side, providing a symmetrical analgesia versus unilateral analgesia.
However, the practice of CSE and epidural catheter placement relies on the palpation of anatomical landmarks that are not always easy to feel. Therefore, the epidural needle maybe placed "off midline" despite positive loss of resistance (LOR) that causes negative CSF flow in the spinal needle and an incorrectly placed catheter. As a result, the incorrect catheter placement will result in a "failed" or suboptimal epidural analgesia.
Ultrasound has recently been utilized to facilitate lumbar epidurals and spinals. The US imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.
A previous study done by the research team, comparing "blind" vs US guidance technique. It did not show any significant difference in term of success rate or complications with either technique. However, the study was done by 4 trained physicians with lot of practice. At this level of training, the investigators did not observe any technique improvement with US. Which is why the investigators thought might have more success in showing an improvement in technique, with junior residents rotating for the first time on the floor. The idea is to see if there is any difference in their learning curve using the US versus the "blind" technique. Each resident will be their own control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Active Comparator | Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started |
|
| No ultrasound | Active Comparator | Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Learning Curve of Anesthesia Residents | The success rate of epidural with each technique and improvement | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Attempts | The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique. | 30 minutes |
| Percentage of Accurate Epidural Placement | Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Orlando, MD | Mount-Sinai Roosevelt Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount-Sinai Roosevelt Hospital | New York | New York | 10019 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound | Patients that had Ultrasound guided CSE placed Ultrasound: The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia. Epidural infusion: An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups |
| FG001 | No Ultrasound | Patients that had CSE placed using palpation of anatomical landmarks No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia Epidural infusion: An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound | Ultrasound guided CSE placed Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia. Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc |
| BG001 | No Ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Learning Curve of Anesthesia Residents | The success rate of epidural with each technique and improvement | Data not collected | Posted | 1 month |
|
1 Day
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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 | Ultrasound guided CSE placed Ultrasound used for the correct interspace and midline position are identified for correct placement of the CSE analgesia. Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Orlando | Icahn School of Medicine at Mount Sinai | 917-496-7490 | barbara.orlando@mountsinai.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2017 | Mar 19, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| No ultrasound | Procedure | Palpation of anatomical landmarks is used for placement of labor analgesia |
|
| Epidural infusion | Procedure | An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups |
|
| 2 hours |
| Number of Angle Adjustments in Space | The number of angle adjustments of the epidural needle via ultrasound guided CSE technique. | 30 minutes |
CSE placed using palpation of anatomical landmarks No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
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| Secondary | Number of Attempts | The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique. | Posted | Mean | Full Range | attempts | 30 minutes |
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|
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| Secondary | Percentage of Accurate Epidural Placement | Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed | Posted | Number | percentage of accurate placement | 2 hours |
|
|
|
| Secondary | Number of Angle Adjustments in Space | The number of angle adjustments of the epidural needle via ultrasound guided CSE technique. | Posted | Mean | Full Range | adjustments | 30 minutes |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | No Ultrasound | CSE placed using palpation of anatomical landmarks No ultrasound: Palpation of anatomical landmarks is used for placement of labor analgesia Epidural infusion - Bupivacaine 0.0625% with 2mcg fentanyl/cc | 0 | 14 | 0 | 14 | 0 | 14 |
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