Pregnancy
Conditions
Keywords
Pregnancy, Epidural, Labor
Brief summary
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.
Detailed description
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.
Interventions
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.
Palpation of anatomical landmarks is used for placement of labor analgesia
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
Sponsors
Study design
Eligibility
Inclusion criteria
* Nulliparous * Term (\>37 weeks gestation) * Vertex presentation * Singleton gestation * Ability to provide informed consent * Request for analgesia for labor pain * Maternal age 18 years or greater
Exclusion criteria
* Multiparous * Preterm (\< 37 weeks gestation) * Presentation other than vertex (breech, transverse) * Active drug/alcohol dependence * Previous spinal surgeries * Known spinal deformities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Learning Curve of Anesthesia Residents | 1 month | The success rate of epidural with each technique and improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts | 30 minutes | The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique. |
| Percentage of Accurate Epidural Placement | 2 hours | Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed |
| Number of Angle Adjustments in Space | 30 minutes | The number of angle adjustments of the epidural needle via ultrasound guided CSE technique. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| 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 | 14 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Data lost | 3 | 5 |
| Overall Study | Lack of Efficacy | 0 | 1 |
Baseline characteristics
| Characteristic | Ultrasound | No Ultrasound | Total |
|---|---|---|---|
| Age, Customized 21 years and over | 9 Participants | 14 Participants | 23 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 14 |
| other Total, other adverse events | 0 / 9 | 0 / 14 |
| serious Total, serious adverse events | 0 / 9 | 0 / 14 |
Outcome results
Learning Curve of Anesthesia Residents
The success rate of epidural with each technique and improvement
Time frame: 1 month
Population: Data not collected
Number of Angle Adjustments in Space
The number of angle adjustments of the epidural needle via ultrasound guided CSE technique.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ultrasound | Number of Angle Adjustments in Space | 1.78 adjustments |
| No Ultrasound | Number of Angle Adjustments in Space | 1.28 adjustments |
Number of Attempts
The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ultrasound | Number of Attempts | 1.333 attempts |
| No Ultrasound | Number of Attempts | 1.357 attempts |
Percentage of Accurate Epidural Placement
Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound | Percentage of Accurate Epidural Placement | 66 percentage of accurate placement |
| No Ultrasound | Percentage of Accurate Epidural Placement | 86 percentage of accurate placement |