Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients

NCT03100968 | Completed Results DMC FDA Device

• 1 other identifier: F150402002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural.

Conditions

Epidural Anesthesia; Spinal Ultrasound; Obesity

Outcome Measures

Primary Outcomes (3)

• Time for Epidural Placement

  Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.

  Baseline up to 1 hour

• Number of Needle Passes

  Baseline up to 1 hour

• Total Time

  Baseline up to 1 hour

Secondary Outcomes (3)

• Time to Identify Midline

  Baseline up to 1 hour

• Epidural Failure Rate

  Baseline up to 1 hour

• Number of Top-offs Required

  Baseline up to 1 hour

Study Arms (2)

Palpation Group

ACTIVE COMPARATOR

The palpation group will have an epidural placed after manual palpation of the spine.

Procedure: Palpation

Ultrasound Group

ACTIVE COMPARATOR

The ultrasound group will have an epidural placed after identifying midline with the ultrasound.

Device: Ultrasound

Interventions

Palpation PROCEDURE

Traditional epidural methods used for the identification of the midline using palpation prior to procedure

Palpation Group

Ultrasound DEVICE

Lumbar spinal ultrasound performed for identification of the midline prior to procedure.

Ultrasound Group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Gender Eligibility Details: All female parturients in active labor
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patient request for a labor epidural
• BMI≥35

You may not qualify if:

• BMI\<35
• patient refusal of a labor epidural
• coagulopathy
• platelets\<80,000
• prior spine procedure or instrumentation
• a diagnosis of scoliosis
• an intracranial or spinal mass

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Adam Sturdivant
• Organization: University of Alabama at Birmingham

Adamsturdivant@uabmc.edu

205-934-4042

Study Officials

• Mark F Powell, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Upon enrollment into the study, participants will be randomized 1:1 to either ultrasound or palpation. Randomization will be performed via random drawing: the provider will randomly select a card assigning the method of midline identification (i.e., ultrasound or palpation). Anesthesia providers will not be randomized. Any qualified provider available to place the epidural will be the person to perform the procedure.

Study Record Dates

• First Submitted: March 25, 2017
• First Posted: April 4, 2017
• Study Start: June 22, 2015
• Primary Completion: October 1, 2018
• Study Completion: September 1, 2021
• Last Updated: September 29, 2021
• Results First Posted: September 17, 2019

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)