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

NCT02207972 | Completed Results

• 1 other identifier: IRB #12-172
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnant; labor; Epidural

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Accurate Epidural Placement

  Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position

  2 hours

Secondary Outcomes (2)

• Number of Participants With Successful First Attempt

  Immediate

• Number of Participants Without Angle Adjustments in Space Success

  immediate

Study Arms (2)

Use of Ultrasound

ACTIVE COMPARATOR

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

No ultrasound used

ACTIVE COMPARATOR

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

Interventions

Use of Ultrasound DEVICE

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.

Use of Ultrasound

No ultrasound used PROCEDURE

Palpation of anatomical landmarks is used for placement of labor analgesia

No ultrasound used

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Multiparous
• Preterm (\< 37 weeks gestation)
• Presentation other than vertex (breech, transverse)
• Active drug/alcohol dependence
• Previous spinal surgeries
• Known spinal deformities

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

Mount-Sinai Roosevelt hospital

New York, New York, 10019, United States

Location

Results Point of Contact

• Title: Dr Barbara Orlando MD and PI
• Organization: Mount Sinai West

barbara.orlando@mountsinai.org

2125236915

Study Officials

• Migdalia Saloum, MD

  Mount Sinai Roosevelt Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: May 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 13, 2018
• Results First Posted: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)