Pregnancy
Conditions
Keywords
Pregnant, labor, Epidural
Brief summary
The investigators believe that ultrasound guided CSE technique will accurately place the epidural needle in the midline position compared to epidural needle placement via palpation of anatomical landmarks. This will result in positive CSF in the spinal needle, correct placement of the catheter, and 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.
Interventions
DEVICEUse of 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.
PROCEDURENo ultrasound used
Palpation of anatomical landmarks is used for placement of labor analgesia
Sponsors
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
* Nulliparious * 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 |
|---|---|---|
| Number of Participants With Accurate Epidural Placement | 2 hours | Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful First Attempt | Immediate | The number of participants who had first attempt success to locate the epidural space and midline position |
| Number of Participants Without Angle Adjustments in Space Success | immediate | the number of participants with successes without any readjustment of the angle in the space |
Countries
United States
Participant flow
Recruitment details
Patients in labor requesting epidural will be offered to participate in the study for their neuraxial placement
Pre-assignment details
Once the patient agrees to be in the study, they will be randomized into one of the 2 arms (with or without ultrasound) for their neuraxial placement.
Participants by arm
| Arm | Count |
|---|---|
| Use of Ultrasound Woman requests epidural for pain relief Ultrasound guided CSE placed Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml
Use of 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. | 22 |
| No Ultrasound Used Palpation of anatomical landmarks Woman requests epidural for pain relief CSE placed using palpation of anatomical landmarks Continuous epidural infusion started Infusion 12 ml/hr of 0.0625% Bupivacaine and Fentanyl 2mcg/ml
No ultrasound used: Palpation of anatomical landmarks is used for placement of labor analgesia | 24 |
| Total | 46 |
Baseline characteristics
| Characteristic | Use of Ultrasound | No Ultrasound Used | Total |
|---|---|---|---|
| Age, Continuous | 31.83 years | 31.85 years | 31.84 years |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 22 Participants | 24 Participants | 46 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 / 22 | 0 / 24 |
| other Total, other adverse events | 0 / 22 | 0 / 24 |
| serious Total, serious adverse events | 0 / 22 | 0 / 24 |
Outcome results
Primary
Number of Participants With Accurate Epidural Placement
Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Use of Ultrasound | Number of Participants With Accurate Epidural Placement | 21 Participants |
| No Ultrasound Used | Number of Participants With Accurate Epidural Placement | 23 Participants |
Secondary
Number of Participants Without Angle Adjustments in Space Success
the number of participants with successes without any readjustment of the angle in the space
Time frame: immediate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Use of Ultrasound | Number of Participants Without Angle Adjustments in Space Success | 16 Participants |
| No Ultrasound Used | Number of Participants Without Angle Adjustments in Space Success | 12 Participants |
Secondary
Number of Participants With Successful First Attempt
The number of participants who had first attempt success to locate the epidural space and midline position
Time frame: Immediate
Population: Pregnant patients in labor requesting neuraxial analgesia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Use of Ultrasound | Number of Participants With Successful First Attempt | 19 Participants |
| No Ultrasound Used | Number of Participants With Successful First Attempt | 21 Participants |