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Carotid endarterectomy is commonly conducted under regional (deep, superficial, intermediate, or combined) cervical plexus block, but it is not known if complication rates differ. We conducted a systematic review of published papers to assess the complication rate associated with superficial (or intermediate) and deep (or combined deep plus superficial/intermediate). The null hypothesis was that complication rates were equal. Complications of interest were: (1) serious complications related to the placement of block, (2) incidence of conversion to general anaesthesia, and (3) serious systemic complications of the surgical-anaesthetic process. We retrieved 69 papers describing a total of 7558 deep/combined blocks and 2533 superficial/intermediate blocks. Deep/combined block was associated with a higher serious complication rate related to the injecting needle when compared with the superficial/intermediate block (odds ratio 2.13, P = 0.006). The conversion rate to general anaesthesia was also higher with deep/combined block (odds ratio 5.15, P < 0.0001), but there was an equivalent incidence of other systemic serious complications (odds ratio 1.13, P = 0.273; NS). We conclude that superficial/intermediate block is safer than any method that employs a deep injection. The higher rate of conversion to general anaesthesia with the deep/combined block may have been influenced by the higher incidence of direct complications, but may also suggest that the superficial/combined block provides better analgesia during surgery. [ABSTRACT FROM AUTHOR]

Free fatty acid (FFA) particles that originate from the enzymatic hydrolysis of polysorbate (PS) via co-purified host cell proteins generally appear abruptly in drug products during real-time (long-term) storage. Efforts were taken to understand the kinetics of FFA particle formation, aiming for a mitigation strategy. However, it is rather challenging particularly in the sub-visible particle (SVP) range, due to either the insufficient sensitivity of the analytical techniques used or the interference of the formulation matrices of proteinaceous drug products. In this study, we examined the feasibility of Raman microscopy, backgrounded membrane imaging (BMI) and total holographic characterization (THC) on the detection of FFA sub-visible particles (SVPs). The results indicate that THC is the most sensitive technique to track their occurrence during the course of PS hydrolysis. Moreover, with this technique we are able to distinguish different stages of FFA particle formation in the medium. In addition, a real time stability study of a biopharmaceutical was analyzed, demonstrating the viability of THC to monitor SVPs in a real sample and correlate it to the visible particles (VPs) occurrence., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)