NCT02747238

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DEVICE	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.
PROCEDURE	No ultrasound	Palpation of anatomical landmarks is used for placement of labor analgesia
PROCEDURE	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

Timeline

• Start date: 2018-01-29
• Primary completion: 2020-02-24
• Completion: 2020-02-24
• First posted: 2016-04-21
• Last updated: 2021-04-15
• Results posted: 2021-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study