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Clinical trial results highlight benefits of RIVANNA Accuro for spinal anesthesia placement

Press releases may be edited for formatting or style | December 18, 2019 Ultrasound
CHARLOTTESVILLE, VA., December 16, 2019 – RIVANNA today announced the results of a recent clinical trial showing that Accuro automated spinal navigation system significantly enhanced the accuracy of spinal anesthesia placement compared to the traditional palpation-based approach in obese patients undergoing orthopedic surgery. Published in the most recent issue of the Regional Anesthesia & Pain Medicine Journal, the trial involved experienced anesthesiologists treating lower limb surgery patients.

“This trial is particularly notable because it proves that neuraxial image guidance is not just a tool to help inexperienced trainees. Anesthesia providers participating in this trial were highly skilled at performing these procedures conventionally,” comments Will Mauldin, PhD, co-founder and CEO of RIVANNA, the device manufacturer and marketer. “Yet, in this patient population, they still benefitted statistically and clinically from Accuro’s automated image guidance technology.”

In the trial, researchers found that patients given a spinal block under Accuro ultrasound-based spinal navigation experienced a median number of 3 needle redirects (from 0 to 9) and 1 needle pass through the skin (from 1 to 2) compared to 6 (from 1 to 16) and 1 (between 1 and 2) respectively for conventional spinal palpation for bony landmarks. Both endpoints were statistically significant in this study enrolling 130 patients.

Obese body mass index (BMI) is associated with increased complications during the delivery of neuraxial anesthesia, including epidural, spinal and combined spinal-epidural (CSE) procedures, due to physician difficulty, whatever their level of experience, in identifying bony landmarks in this population. These landmarks guide physicians in identifying the appropriate site for needle placement.

For patients, additional needle redirects prolong the procedure and cause added pain and discomfort, and are often accompanied by patient dissatisfaction. Other negative consequences associated with sub-optimal neuraxial anesthesia placements include postdural puncture headaches, back pain, and in very rare instances, paralysis.

The trial, conducted at the Rizzoli Orthopedic Institute in Bologna, Italy, examined patients aged 18 to 75 with a BMI above 30 kg/m with American Society of Anesthesiologists Physical Status of I-III. Its primary aim was to examine the number of needle redirects required to complete the procedure when conducted with and without Accuro’s ultrasound (US)-based guidance. In the study, redirection was defined as needle advancement preceded by a withdrawal of 1 cm or more as physicians fine-tuned the site for anesthesia delivery. Skin passes were defined as a single needle introduction through the skin. Participating anesthesiologists were experienced in both conventional palpation and Accuro US techniques.

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