3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
Part of paid clinical trials in Galveston, Texas.
- Sponsor
- The University of Texas Medical Branch, Galveston
- Study ID
- NCT03405311
- Status
- Terminated
Conditions
- Obesity, Morbid
- Pain
- Pregnancy
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rivanna Accuro 3D Ultrasound Device — DEVICEThe treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
- Palpation — OTHERThe 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
Study Details
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).
Key Dates
- Start date
- Feb 20, 2018
- Status verified
- Feb 2026
- Primary completion
- Jan 11, 2024
- Completion
- Jan 11, 2024
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: PalpationThe 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.
- Experimental: Rivanna Accuro 3D Ultrasound DeviceThe treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Primary Outcome Measure
Number of Needle Insertion Attempts Calculated Across All Participants [ Time Frame: Beginning of needle insertion till catheter placement-15 minutes ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas Medical Branch | Galveston | Texas | 77555 | - |
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