BACKGROUND: The Episure™ AutoDetect™ (spring-loaded) syringe has been observed to successfully identify the epidural space in 2 pilot studies. In this study we evaluated the impact of the spring-loaded syringe on the establishment of successful epidural labor analgesia (primary outcome), elapsed time for catheter placement, and learning curve (cumulative summary analysis, i.e., Cusum) of experienced anesthesiologists. METHODS:Fourteen attending and fellow anesthesiologists were randomized to perform 50 consecutive epidural technique attempts using a spring-loaded or conventional glass syringe. Ten participants completed an additional 50 attempts with the alternate syringe in a crossover design. RESULTS: A total of 1200 epidural placement attempts were performed. Use of the spring-loaded syringe was associated with a nonsignificant difference of estimated success rate in obtaining analgesia success (absolute difference of 1.0% 95% confidence interval, CI: -8.9% to 10.8%), shorter elapsed mean time to epidural catheter placement (ratio of 0.92 95% CI, 0.89-0.96); P = 0.003) and similar Cusum curves when compared with a conventional glass syringe. Analgesia success was more common with attending versus fellow anesthesiologists (absolute difference of 34.6% 95% CI, 14.9% to 54.3%; P < 0.001), and when the initial preferred technique was loss-of-resistance to continuous saline versus intermittent air (absolute difference of 33.8% 95% CI, 12.6% to 55.0%; P < 0.001). Shorter elapsed mean times were also observed in the group exposed to the spring-loaded syringe first (ratio of 0.65 95% CI, 0.62-0.67; P = 0.02). CONCLUSIONS: When used by experienced obstetric anesthesiologists, the spring-loaded syringe was associated with a similar overall rate for establishing successful epidural labor analgesia, a shorter elapsed time to epidural catheter insertion, particularly when the anesthesiologist was randomized to use the novel syringe first, and a similar Cusum curve when compared with a conventional glass syringe. Attending versus fellow anesthesiologists and an initial technique preference for loss-of-resistance to continuous saline were associated with greater analgesia success with the novel syringe.
RCT Entities:
BACKGROUND: The Episure™ AutoDetect™ (spring-loaded) syringe has been observed to successfully identify the epidural space in 2 pilot studies. In this study we evaluated the impact of the spring-loaded syringe on the establishment of successful epidural labor analgesia (primary outcome), elapsed time for catheter placement, and learning curve (cumulative summary analysis, i.e., Cusum) of experienced anesthesiologists. METHODS: Fourteen attending and fellow anesthesiologists were randomized to perform 50 consecutive epidural technique attempts using a spring-loaded or conventional glass syringe. Ten participants completed an additional 50 attempts with the alternate syringe in a crossover design. RESULTS: A total of 1200 epidural placement attempts were performed. Use of the spring-loaded syringe was associated with a nonsignificant difference of estimated success rate in obtaining analgesia success (absolute difference of 1.0% 95% confidence interval, CI: -8.9% to 10.8%), shorter elapsed mean time to epidural catheter placement (ratio of 0.92 95% CI, 0.89-0.96); P = 0.003) and similar Cusum curves when compared with a conventional glass syringe. Analgesia success was more common with attending versus fellow anesthesiologists (absolute difference of 34.6% 95% CI, 14.9% to 54.3%; P < 0.001), and when the initial preferred technique was loss-of-resistance to continuous saline versus intermittent air (absolute difference of 33.8% 95% CI, 12.6% to 55.0%; P < 0.001). Shorter elapsed mean times were also observed in the group exposed to the spring-loaded syringe first (ratio of 0.65 95% CI, 0.62-0.67; P = 0.02). CONCLUSIONS: When used by experienced obstetric anesthesiologists, the spring-loaded syringe was associated with a similar overall rate for establishing successful epidural labor analgesia, a shorter elapsed time to epidural catheter insertion, particularly when the anesthesiologist was randomized to use the novel syringe first, and a similar Cusum curve when compared with a conventional glass syringe. Attending versus fellow anesthesiologists and an initial technique preference for loss-of-resistance to continuous saline were associated with greater analgesia success with the novel syringe.