Background We aimed to determine with this randomized, triple-masked, placebo-controlled study if benefits are afforded by adding a multiple-day, ambulatory, continuous ropivacaine paravertebral nerve block to a single-injection ropivacaine paravertebral block following mastectomy. Methods Preoperatively, 60 subjects undergoing unilateral (n = 24) or bilateral (n = 36) mastectomy received either unilateral or bilateral paravertebral perineural catheter(s), respectively, inserted between the third and fourth thoracic transverse process(es). All subjects received an initial bolus of ropivacaine 0.5% (15 mL) via the catheter(s). Subjects were randomized to receive either perineural ropivacaine 0.4% or normal saline using portable infusion pump(s) [5 mL/h basal; 300 mL reservoir(s)]. Subjects remained hospitalized for at least 1 night and were subsequently discharged home where the catheter(s) were removed on postoperative day 3. Subjects were contacted by telephone on postoperative days 1, 4, 8, and 28. The primary end point was average pain (scale: 0–10) queried on postoperative day (POD) 1. Results Average pain queried on POD 1 for subjects receiving perineural ropivacaine (n=30) was a median (interquartile) of 2 (0–3), compared with 4 (1–5) for subjects receiving saline (n = 30; 95% CI difference in medians, −4.0 – −0.3; P = 0.021]. During this same time period, subjects receiving ropivacaine experienced a lower severity of breakthrough pain (5 [3–6] vs 7 [5–8]; P = 0.046) as well. As a result, subjects receiving perineural ropivacaine experienced less pain-induced physical and emotional dysfunction, as measured with the Brief Pain Inventory (lower score = less dysfunction): 14 (4–37) vs 57 (8–67) for subjects receiving perineural saline (P = 0.012). For the subscale that measures the degree of interference of pain on 7 domains, such as general activity and relationships, subjects receiving perineural saline reported a median score 10 times higher than those receiving ropivacaine (3 [0–24] versus 33 [0–44]; P = 0.035). In contrast, following infusion discontinuation there were no statistically significant differences detected between treatment groups. Conclusions Following mastectomy, adding a multiple-day, ambulatory, continuous ropivacaine infusion to a single-injection ropivacaine paravertebral nerve block results in improved analgesia and less functional deficit during the infusion. However, no benefits were identified following infusion discontinuation.
BACKGROUND Hip arthroplasty frequently requires potent postoperative analgesia, often provided with an epidural or posterior lumbar plexus local anesthetic infusion. However, American Society of Regional Anesthesia guidelines now recommend against epidural and continuous posterior lumbar plexus blocks during administration of various perioperative anticoagulants often administered after hip arthroplasty. A continuous femoral nerve block is a possible analgesic alternative, but whether it provides comparable analgesia to a continuous posterior lumbar plexus block after hip arthroplasty remains unclear. We therefore tested the hypothesis that differing the catheter insertion site (femoral versus posterior lumbar plexus) after hip arthroplasty has no impact on postoperative analgesia. METHODS Preoperatively, subjects undergoing hip arthroplasty were randomly assigned to receive either a femoral or posterior lumbar plexus stimulating catheter inserted 5 to 15 cm or 0 to 1 cm past the needletip, respectively. Postoperatively, patients received perineural ropivacaine, 0.2% (basal 6 mL/hour, bolus 4 mL, 30 min lockout) for at least two days. The primary end point was the average daily pain scores as measured with a numeric rating scale (0–10) recorded in the 24-h period beginning at 07:30 the morning after surgery, excluding twice-daily physical therapy sessions. Secondary end points included pain during physical therapy, ambulatory distance, and supplemental analgesic requirements during the same 24-h period, as well as satisfaction with analgesia during hospitalization. RESULTS The mean (SD) pain scores for subjects receiving a femoral infusion (n = 25) were 3.6 (1.8) versus 3.5 (1.8) for patients receiving a posterior lumbar plexus infusion (n = 22) resulting in a group difference of 0.1 (95% confidence interval −0.9 to 1.2; P = 0.78). Because the confidence interval was within a prespecified −1.6 to 1.6 range, we conclude that the effect of the two analgesic techniques on postoperative pain was equivalent. Similarly, we detected no differences between the two treatments with respect to the secondary end points, with one exception: subjects with a femoral catheter ambulated a median (10th–90th percentiles) 2 (0–17) m the morning after surgery, compared with 11 (0–31) m for subjects with a posterior lumbar plexus catheter (data nonparametric; P = 0.02). CONCLUSIONS After hip arthroplasty, a continuous femoral nerve block is an acceptable analgesic alternative to a continuous posterior lumbar plexus block when using a stimulating perineural catheter. However, early ambulatory ability suffers with a femoral infusion.
Background:Whether the method of local anesthetic administration for continuous femoral nerve blocks-basal infusion versus repeated hourly bolus doses-influences block effects remains unknown. Methods: Bilateral femoral perineural catheters were inserted in volunteers (n ϭ 11). Ropivacaine 0.1% was concurrently administered through both catheters: a 6-h continuous 5 ml/h basal infusion on one side and 6 hourly bolus doses on the contralateral side. The primary endpoint was
The COVID‐19 pandemic has produced critical shortages of ventilators worldwide. There is an unmet need for rapidly deployable, emergency‐use ventilators with sufficient functionality to manage COVID‐19 patients with severe acute respiratory distress syndrome. Here, we show the development and validation of a simple, portable and low‐cost ventilator that may be rapidly manufactured with minimal susceptibility to supply chain disruptions. This single‐mode continuous, mandatory, closed‐loop, pressure‐controlled, time‐terminated emergency ventilator offers robust safety and functionality absent in existing solutions to the ventilator shortage. Validated using certified test lungs over a wide range of compliances, pressures, volumes and resistances to meet U.S. Food and Drug Administration standards of safety and efficacy, an Emergency Use Authorization is in review for this system. This emergency ventilator could eliminate controversial ventilator rationing or splitting to serve multiple patients. All design and validation information is provided to facilitate ventilator production even in resource‐limited settings.
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