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      ED 50 of intrathecal ropivacaine for cesarean delivery with and without epidural volume extension with normal saline: a randomized controlled study

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          Abstract

          Background

          It was reported that epidural volume extension could decrease the ED 50 of intrathecal plain bupivacaine. In this study, we investigated the ED 50 of intrathecal hyperbaric ropivacaine followed by epidural normal saline bolus for cesarean section.

          Methods

          Sixty parturients were allocated into two groups in this prospective study. About 10 mL of epidural normal saline was given after the intrathecal dose of hyperbaric ropivacaine in the Group S (normal saline group), and no epidural injection of normal saline was given after the intrathecal ropivacainve injection in the Group C (control group). The dose of intrathecal ropivacaine for each parturient was decided by up-down allocation method. The initial dose was set as 10 mg. Effective anesthesia was defined as the level of T6 or above achieved within 10 minutes after intrathecal injection and no additional epidural drug to complete operation. The Massey formula was applied to calculate the ED 50 of intrathecal ropivacaine.

          Results

          The ED 50 of intrathecal ropivacaine for cesarean section determined by up-and-down method was 7.51 mg (95% CI, 7.09–7.93 mg) in the Group S and 8.29 mg (95% CI, 7.73–8.85 mg) in the Group C, and there was a significant difference in ED 50 of ropivacaine between the two groups ( P<0.05). Compared with the Group C, the ED 50 of intrathecal ropivacaine decreased when followed by epidural normal saline bolus.

          Conclusion

          The ED 50 of intrathecal hyperbaric ropivacaine for cesarean section is 8.29 mg, and it is reduced when followed by epidural normal saline bolus ( www.chictr.org.cn, registration number: ChiCTR-ROC-17013382).

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          Most cited references 18

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          Staircase bioassay: the up-and-down method.

           Marcus Dixon (1990)
          Experiments are conducted to estimate the threshold for an all-or-none response. Threshold is defined to be a point above which 50% of the subjects will respond and below which 50% of the subjects will not respond. Examples are death, death in a fixed time period, shock, fibrillation, emesis. Staircase designs, in particular up-and-down trials, produce median (ED50) estimates of given standard error with as few as one-fifth the number of subjects as the traditional designs with preset numbers of tests at each of several levels of stimulus. We discuss these estimates and their efficiency as well as procedures to estimate standard deviation and its use in designing up-and-down trails. The advantages in using several short series in factorial experiments are presented. Suggestions are given for minimizing the complications of sequential designs. Case studies indicate the efficiency of the design for various applications.
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            Low-dose bupivacaine-fentanyl spinal anesthesia for cesarean delivery.

            The hypotension following spinal anesthesia remains commonplace in cesarean delivery. Intrathecal opioids are synergistic with local anesthetics and intensify sensory block without increasing sympathetic block. The combination makes it possible to achieve spinal anesthesia with otherwise inadequate doses of local anesthetic. We hypothesized that this phenomenon could be used to provide spinal anesthesia for cesarean delivery while incurring less frequent hypotension. Thirty-two women scheduled for cesarean delivery were divided into 2 groups of patients who received a spinal injection of either 10 mg of isobaric (plain) bupivacaine 0.5% or 5 mg of isobaric bupivacaine with 25 microg fentanyl added. Each measurement of a systolic blood pressure less than 95 mm Hg or a decrease in systolic pressure of greater than 25% from baseline was considered as hypotension and treated with a bolus of 5 to 10 mg of intravenous ephedrine. Spinal block provided surgical anesthesia in all patients. Peak sensory level was higher (T3 v T4. 5) and motor block more intense in the plain bupivacaine group. The plain bupivacaine patients were more likely to require treatment for hypotension (94% v 31%) and had more persistent hypotension (4.8 v 0.6 hypotensive measurements per patient) than patients in the minidose bupivacaine-fentanyl group. Mean ephedrine requirements were 23.8 mg and 2.8 mg, respectively, for the 2 groups. Patients in the plain bupivacaine group also complained of nausea more frequently than patients in the minidose bupivacaine-fentanyl group (69% v 31%). Bupivacaine 5 mg + fentanyl 25 microg provided spinal anesthesia for cesarean delivery with less hypotension, vasopressor requirements, and nausea than spinal anesthesia with 10 mg bupivacaine.
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              ED50 and ED95 of intrathecal hyperbaric bupivacaine coadministered with opioids for cesarean delivery.

              Successful cesarean delivery anesthesia has been reported with use of small doses (5-9 mg) of intrathecal bupivacaine coadministered with opioids. This double-blind, randomized, dose-ranging study determined the ED50 and ED95 of intrathecal bupivacaine (with adjuvant opioids) for cesarean delivery anesthesia. Forty-two parturients undergoing elective cesarean delivery with use of combined spinal-epidural anesthesia received intrathecal hyperbaric bupivacaine in doses of 6, 7, 8, 9, 10, 11, or 12 mg in equal volumes with an added 10 microg intrathecal fentanyl and 200 microg intrathecal morphine. Sensory levels (pinprick) were evaluated every 2 min until a T6 level was achieved. The dose was a success(induction) if a bilateral T6 block occurred in 10 min; otherwise, it was a failure(induction). In addition to being a success(induction), the dose was a success(operation) if no intraoperative epidural supplement was required; otherwise, it was a failure(operation). ED50 and ED95 for both success(induction) and success(operation) were determined with use of a logistic regression model. ED50 for success(induction) and success(operation) were 6.7 and 7.6 mg, respectively, whereas the ED95 for success(induction) and success(operation) were 11.0 and 11.2 mg. Speed of onset correlated inversely with dose. Although no clear advantage for low doses could be demonstrated (hypotension, nausea, vomiting, pruritus, or maternal satisfaction), this study was underpowered to detect significance in these variables. The ED95 of intrathecal bupivacaine under the conditions of this study is considerably in excess of the low doses proposed for cesarean delivery in some recent publications. When doses of intrathecal bupivacaine less than the ED95, particularly near the ED50, are used, the doses should be administered as part of a catheter-based technique.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2018
                08 November 2018
                : 11
                : 2791-2796
                Affiliations
                [1 ]Department of Obestetrics and Gynecology, Affiliated Women and Children’s Hospital of Jiaxing University, Jiaxing, China
                [2 ]Department of Anesthesiology, Affiliated Women and Children’s Hospital of Jiaxing University, Jiaxing, China
                [3 ]Institute of Clinical Research, Jiaxing university, Jiaxing, China, zjjiaxing0573@ 123456qq.com
                Author notes
                Correspondence: Z Wang, Institute of Clinical Research, Jiaxing university, No. 2468, Zhonghuan Road, Jiaxing City 314000, China, Tel +86 5 738 271 0085, Email zjjiaxing0573@ 123456qq.com
                Article
                jpr-11-2791
                10.2147/JPR.S174176
                6235342
                30519082
                © 2018 Lv et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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