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

NCT03405311 | Terminated Results DMC FDA Device

• 1 other identifier: 17-0286
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity, Morbid; Pregnancy; Pain

Keywords

Labor analgesia; Ultrasound; Obesity, Morbid; Pregnancy; Labor Epidural Analgesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale

  Beginning of needle insertion till catheter placement-15 minutes

• Needle Depth

  Beginning of needle insertion till catheter placement-15 minutes

• Pressure Pain Thresholds

  Before epidural placement

• Number of Complications Recorded Calculated Across All Participants

  Within 30 days of admission

Study Arms (2)

Palpation

ACTIVE COMPARATOR

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

Rivanna Accuro 3D Ultrasound Device

EXPERIMENTAL

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

Interventions

Rivanna Accuro 3D Ultrasound Device DEVICE

The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device

Rivanna Accuro 3D Ultrasound Device

Palpation OTHER

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

Palpation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Links

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

MeSH Terms

Conditions

Obesity, Morbid; Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Rovnat Babazade
• Organization: University of Texas Medical Branch, Galveston

robabaza@utmb.edu

(409)772-1011

Study Officials

• Rovnat Babazade, MD

  The University of Texas Medical Branch

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 23, 2018
• Study Start: February 20, 2018
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-02

Locations

US (1)