3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient

3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient: A Randomized Control Trial

This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device).

Study Overview

• Status: Terminated
• Conditions: Pain; Pregnancy; Obesity, Morbid
• Intervention / Treatment: Other: Palpation; Device: Rivanna Accuro 3D Ultrasound Device

Detailed Description

Worldwide obesity has become an epidemic. The obstetrical population is no exception. This made more challenging for anesthesiologists on labor and delivery units to administer epidural analgesia. According to the World Health Organization, more than 30% of U.S. adults are obese with a body mass index (BMI; in kg/m2) ≥ 30. Recent data has shown that increased BMI has been associated with increased neuraxial analgesic failure and difficulty with prolonged epidural placement time.

The 'Blind approach' is the current standard of care in administering neuraxial anesthesia. The physician palpates the patient's spinal bony landmarks; the needle is placed in relation to identified landmarks and inserted until loss of resistance is felt. In the obese population, the success rates are as low as 68%. Recently the FDA has approved a handheld device "The Accuro" as an adjunct for neuraxial analgesia (Rivanna Medical, LLC). It consists of a three-dimensional ultrasound device. By utilizing sound waves it constructs three-dimensional images of the spinal column, allowing the physician to better see the spine in order to perform spinal/epidural anesthesia.

Hypothesize that this device will enable clinicians to assess epidural spaces for epidural needle placement compared with the traditional Blind approach in the morbidly obese parturient.

This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device). Also, will determine if ultrasound based landmarks would reduce the needle tract and thereby reduced the amount of post-procedure pain at the insertion site in the peripartum period by using the algometer.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • The University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists physical status class I, II, or III.
• Term pregnancy.
• Requesting epidural analgesia for anticipated vaginal delivery.
• BMI>or = 40.

Exclusion Criteria:

• Contraindication for epidural analgesia
• Inability to adequately understand the consent form.
• Incarcerated patients.
• Patients with known spinal deformities.
• Allergies to ultrasound gel.
• Allergies to local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palpation; The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.	Other: Palpation; The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
Experimental: Rivanna Accuro 3D Ultrasound Device; The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.	Device: Rivanna Accuro 3D Ultrasound Device; The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Needle Insertion Attempts Calculated Across All Participants	An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.	Beginning of needle insertion till catheter placement-15 minutes
Number of Participants With Successful Epidural Catheter Placements	Number of Participants With Successful Epidural Catheter Placements.	Within first 90 minutes following catheter placement
Number of Needle Insertion Redirections Calculated Across All Participants	An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.	Beginning of needle insertion till catheter placement-15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale	Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult).	Beginning of needle insertion till catheter placement-15 minutes
Needle Depth	We will also record thouy needle depth from skin and measured depth by ultrasound.	Beginning of needle insertion till catheter placement-15 minutes
Pressure Pain Thresholds	Pressure pain thresholds will be obtained immediately prior to the epidural placement using the pressure pain device.	Before epidural placement
Number of Complications Recorded Calculated Across All Participants	The number of complications related to the epidural recorded within 30 days of admission.	Within 30 days of admission

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Rovnat Babazade, MD, The University of Texas Medical Branch

Publications and helpful links

Helpful Links

• 510(k) clearance for the Rivanna Accuro ultrasound device

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Pregnancy; Labor analgesia; Obesity, Morbid; Labor Epidural Analgesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pain; Obesity, Morbid
• Other Study ID Numbers: 17-0286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No