Trial results for a study investigating 3D ultrasound-guided labor epidural analgesia in morbidly obese parturients were posted on ClinicalTrials.gov on 2026-02-17. The terminated trial, which enrolled 40 participants, compared the Rivanna Accuro 3D Ultrasound Device to a palpation-based approach, finding similar outcomes across several key metrics.
Background
Morbid obesity can present challenges for medical procedures, including the placement of epidural analgesia during labor. Accurate and efficient epidural catheter placement is crucial for pain management in parturients. This trial aimed to evaluate whether a 3D ultrasound device could improve the success rates of epidural analgesia compared to traditional palpation methods in this specific patient population.
Trial design
This randomized control study, designated as Phase NA, was terminated and enrolled 40 participants. The trial focused on conditions including Obesity, Morbid, Pregnancy, and Pain. The objective was to evaluate epidural analgesia success rates between two methods: a palpation-based approach and the Rivanna Accuro 3D Ultrasound Device.
Key results
The study reported on several key measurements comparing the Palpation group (n=20) and the Rivanna Accuro 3D Ultrasound Device group (n=20):
- Number of Needle Insertion Attempts Calculated Across All Participants: Both the Palpation group and the Rivanna Accuro 3D Ultrasound Device group recorded 2 attempts.
- Number of Participants With Successful Epidural Catheter Placements: Both the Palpation group and the Rivanna Accuro 3D Ultrasound Device group had 20 participants with successful placements.
- Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale: The mean difficulty score was 3 for both the Palpation group and the Rivanna Accuro 3D Ultrasound Device group.
- Needle Depth: The mean needle depth was 7.2 cm (Standard Deviation 1.3) for both the Palpation group and the Rivanna Accuro 3D Ultrasound Device group.
- Pressure Pain Thresholds: The median pressure pain threshold was 48 Newtons (Standard Deviation 19) for the Palpation group and 45 Newtons (Standard Deviation 19) for the Rivanna Accuro 3D Ultrasound Device group.
- Number of Complications Recorded Calculated Across All Participants: Both groups reported 0 complications.
What this means
The results of this terminated trial suggest that the Rivanna Accuro 3D Ultrasound Device performed similarly to the traditional palpation method for epidural analgesia in morbidly obese parturients across several measured outcomes. Key metrics such as needle insertion attempts, successful catheter placements, procedural difficulty, needle depth, and complications were comparable between the two approaches. While the trial was terminated, the available data indicates that the ultrasound device did not offer a distinct advantage over palpation in the parameters evaluated.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03405311, titled "3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient", were posted on 2026-02-17 on clinicaltrials.gov.