Does Ultrasound Help With Placement of Labor Analgesia in Pregnant Patients?

Does Ultrasound-guided CSE Technique Improve Midline Placement of Epidural Needle With Positive CSF Flow, Thereby Facilitating Correct Placement of the Catheter Compared to Catheter Placement Using Palpation of Anatomical Landmarks?

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Use of Ultrasound; Procedure: No ultrasound used

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount-Sinai Roosevelt Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: 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.
Active Comparator: 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	Procedure: No ultrasound used; Palpation of anatomical landmarks is used for placement of labor analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Accurate Epidural Placement	Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful First Attempt	The number of participants who had first attempt success to locate the epidural space and midline position	Immediate
Number of Participants Without Angle Adjustments in Space Success	the number of participants with successes without any readjustment of the angle in the space	immediate

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Investigators: Principal Investigator: Migdalia Saloum, MD, Mount Sinai Roosevelt Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Epidural; labor; Pregnant
• Other Study ID Numbers: IRB #12-172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO