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Investigation of the Minimum Local Analgesic Concentration of Epidural Sufentanil Combined With Ropivacaine for Labor Analgesia
Affiliation:1. Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Embryo Original Disease, Shanghai Municipal Key Clinical Specialty, Huashan Rd. 1961, Shanghai, 200030, China;2. School of Nursing, Guangdong Pharmaceutical University, Guangzhou, 510310, China;3. Department of Anesthesiology, Women and Children''s Hospital, Jiaxing University, Jiaxing 314000, China;1. CSL Behring LLC, King of Prussia, PA, USA;2. CSL Behring AG, Bern, Switzerland;1. Department of Pharmacy, Peking University Third Hospital, Beijing, China;2. Medical Decision and Economic Group, Department of Pharmacy, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China;3. Health Economics and Outcomes Research, Boehringer Ingelheim (China), Beijing, China;4. ExtroPharm Inc, Shanghai, China;1. Department of Clinical Geriatric, University Hospital Center, Limoges, France;2. HAVAE EA 6310 Laboratory, University of Limoges, Limoges, France;3. PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France;4. UPSAV, Department of Clinical Geriatric, University Hospital Center, Limoges, France;5. Department of Stomatology and the Montreal Research Center, Institute of Geriatrics, University of Montreal, Montreal, Quebec, Canada;6. Spine & Neuromodulation Functional Unit, Poitiers University Hospital, Poitiers, France;7. Prime Institute, University of Poitiers, Poitiers, France
Abstract:PurposeWorldwide, there are only few studies focusing on labor analgesia on the MLAC (minimum local analgesic concentration) or EC50 (median effective concentration) of sufentanil and ropivacaine. Therefore, we determine the MLAC or EC50 of sufentanil and ropivacaine for epidural analgesia by using an up–down sequential allocation and survey its adverse effect in a prospective blinded randomized trial.MethodsSixty nulliparous full-term parturients who required labor analgesia were recruited and randomly divided into the sufentanil and ropivacaine groups. The formulation was 25 μg sufentanil combined with 0.1% ropivacaine (added 0.9% normal saline to 75 ml). According to the response of a previous parturient, the dosage of sufentanil was increased or decreased by 5 μg in the sufetanil group; meanwhile, we also administrated an initial concentration of 0.1% ropivacaine combined with 22.5 μg sufentanil (added 0.9% normal saline to 75 ml) in the ropivacaine group. The concentration of ropivacaine was increased or decreased by 0.01% following the response of the previous parturient. The Brownlee up–down sequential allocation was used to estimate the MLAC of epidural ropivacaine and its 95% confidence intervals in labor analgesia.FindingsThere were no significant changes for the two groups, including for age, height weight, active stage, second stage of labor, and gestational weeks (P = 0.769, 0.900, 0.603, 0.441, 0.577, and 0.695, respectively). The VAS scores of the parturient decreased to varying degrees (P < 0.0001) after labor analgesia compared with VAS before labor analgesia, and the most effective analgesia was reached in 60 min. The EC50 dose of epidural ropivacaine combined with 0.3 μg/mL sufentanil was 0.09687%, and the 95% CI was 0.08944%~0.1043%. Five parturients had PONV, and the incidence rate was 16.7%; one parturient had pruritus, so the incidence rate was 3.3%. The EC50 dose of epidural sulfetanil combined with 0.1% ropivacaine was 18.76 μg with a 95% confidence interval of 13.5–24.48 μg. There were no significant differences in the active stage, second stage of labor, and maternal and fetal hemodynamic data between the two groups. Notably, the Apgar scores for 1 min and 5 min were 10 scores for almost all of these patients. There were no significant differences between the two groups for maternal and fetal side effects, which had very low incidence rates.ImplicationsThe MLAC of epidural sufentanil or ropivacaine could provide satisfactory and safe analgesia for parturients while having a low incidence rate of side effects.
Keywords:Ropivacaine  sufentanil  epidural labor analgesia  dose effect relation  EC50
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