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

NCT02747238 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-04-15

Study results available
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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.

Conditions

  • Pregnancy

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Barbara Orlando, MD · Mount-Sinai Roosevelt Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2020-02-24
Completion
2020-02-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02747238 on ClinicalTrials.gov