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Does Ultrasound Help Junior Anesthesia Residents With Placement of Labor Analgesia in Pregnant Patients

Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle Thereby Helping Junior Residents With Correct Placement of the Catheter Compared to the Placement Using With Anatomical Landmarks?

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02747238
Enrollment
32
Registered
2016-04-21
Start date
2018-01-29
Completion date
2020-02-24
Last updated
2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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

DEVICEUltrasound

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

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

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

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

* 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

MeasureTime frameDescription
Learning Curve of Anesthesia Residents1 monthThe success rate of epidural with each technique and improvement

Secondary

MeasureTime frameDescription
Number of Attempts30 minutesThe number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.
Percentage of Accurate Epidural Placement2 hoursPercentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed
Number of Angle Adjustments in Space30 minutesThe number of angle adjustments of the epidural needle via ultrasound guided CSE technique.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total23

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyData lost35
Overall StudyLack of Efficacy01

Baseline characteristics

CharacteristicUltrasoundNo UltrasoundTotal
Age, Customized
21 years and over
9 Participants14 Participants23 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
9 Participants14 Participants23 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 14
other
Total, other adverse events
0 / 90 / 14
serious
Total, serious adverse events
0 / 90 / 14

Outcome results

Primary

Learning Curve of Anesthesia Residents

The success rate of epidural with each technique and improvement

Time frame: 1 month

Population: Data not collected

Secondary

Number of Angle Adjustments in Space

The number of angle adjustments of the epidural needle via ultrasound guided CSE technique.

Time frame: 30 minutes

ArmMeasureValue (MEAN)
UltrasoundNumber of Angle Adjustments in Space1.78 adjustments
No UltrasoundNumber of Angle Adjustments in Space1.28 adjustments
Secondary

Number of Attempts

The number of attempts to locate the epidural space and midline position via ultrasound guided CSE technique.

Time frame: 30 minutes

ArmMeasureValue (MEAN)
UltrasoundNumber of Attempts1.333 attempts
No UltrasoundNumber of Attempts1.357 attempts
Secondary

Percentage of Accurate Epidural Placement

Percentage of accurate epidural placement assessed by participant reporting pain 2 hours after CSE placed

Time frame: 2 hours

ArmMeasureValue (NUMBER)
UltrasoundPercentage of Accurate Epidural Placement66 percentage of accurate placement
No UltrasoundPercentage of Accurate Epidural Placement86 percentage of accurate placement

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026