Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation

NCT ID: NCT04020042

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2021-03-23

Brief Summary

Ultrasound is widely in uses for vascular, nerve block and sometimes neuraxial block. The purpose of the study is to evaluate the impact of a handheld ultrasound device on the time to complete labor epidural placement and success rate of epidural analgesia in parturients with a wide range of body mass indexes (BMIs).

A handheld ultrasound device (Accuro, Rhivanna Medical, Charlottesville, VA) may eliminate the time for equipment setup due to its portability and instant power-up. In addition, it provides a simulated diagram to aid in identifying bone and lumbar spaces. These unique features may be helpful in laboring women with a particular BMI range. We aim to define the usefulness of guidance with a handheld ultrasound in completing labor epidural analgesia in various BMIs.

The primary outcome: The time needed to complete epidural placements.

Secondary outcomes:

• The number of needle insertion attempts,
• The rate of success measured by the need to replacements during the labor course for vaginal or cesarean delivery.

Detailed Description

This randomized prospective clinical trial aims to evaluate timing savings in performing labor epidural analgesia and the success rate of labor analgesia with and without the guidance of a handheld ultrasound device in various BMI groups.

In routine clinical setting, patients admitted to clinic and evaluated labor condition. If patient in active labor and request epidural for labor pain, the standard care team inform obstetric anesthesia epidural team by using pager. Standard of care anesthesia epidural team perform preoperative evaluation and placed the catheter.

The patients in active labor will receive labor epidural analgesia, regardless of the study participation. There is no changes epidural local anesthetic type and doses. The research intervention is only placing hand-hold ultrasound to the back of the patient and see the land mark visually before the epidural catheter placement. The remaining catheter placement is the same as the control group.

Study Procedures:

A Total of 300 eligible parturients will be randomly assigned to one of the two groups either the ultrasound imaging guidance or the traditional landmark palpation group for labor epidural needle placement. The research intervention is simply placing a hand-held ultrasound device on the back of the patient and insert the epidural needle with ultrasound image guidance.

Parturient will receive epidural catheter regardless of the study participation. In the traditional landmark method, anesthetist palpates the structure to determine the site of the initial needle insertion site. The needle will be protruded as in usual standard practice. Anesthetist may remove and insert needle again until feeling epidural space. When anesthetist determine the tip of the needle is in the epidural space, the epidural catheter will be protruded through the needle.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ultrasound imaging guidance

Determination of epidural needle site by using ultrasound guidance

Group Type: EXPERIMENTAL

Ultrasound image guidance

Intervention Type: OTHER

Epidural landmarks will be determined with using ultrasound image

Traditional landmark palpation

Depermination of epidural needle site by using traditional landmark method

Group Type: ACTIVE_COMPARATOR

Landmark palpation

Intervention Type: OTHER

Epidural landmarks will be determined with palpation

Interventions

Ultrasound image guidance

Epidural landmarks will be determined with using ultrasound image

Intervention Type: OTHER

Landmark palpation

Epidural landmarks will be determined with palpation

Intervention Type: OTHER

Other Intervention Names

Determination of epidural lanmakrks with palpation

Eligibility Criteria

Inclusion Criteria

• Age 18-50 years
• Parturient in active labor and desires labor epidural for pain relief.
• American Society of Anesthesiologists (ASA) Class I, 2 and 3 parturients, which include normal parturients
• Parturients with morbidities (including obesity) that are not life-threatening,
• Parturient BMI ≥ 25

Exclusion Criteria

• History of scoliosis or back surgery
• Patient refusal
• Patient with elevated intracranial pressure
• Any patient with a contraindication for placement of epidural anesthesia, including infection at needle insertion site, or coagulopathy.
• ASA Class 4

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Weike Tao

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seema Dave, MPH

Role: STUDY_DIRECTOR

UT Southwestern Medical Center

Locations

Parkland Health Hospital System

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2019-0571

Identifier Type: -

Identifier Source: org_study_id