探讨不同温度局部麻醉药物的分娩镇痛效果及其不良反应发生情况。

选取2017年1月30日至2018年1月10日，于深圳市宝安区妇幼保健院分娩的102例初产妇为研究对象。采用随机数字表法，将其随机分为观察组(n＝52)与对照组(n＝50)。2组初产妇分娩均采用连续硬膜外镇痛，采用的局部麻醉药物一致，但是温度不同，对照组局部麻醉药物为室温(24 ℃)，观察组局部麻醉药物预热至人体体温(37 ℃)。观察2组初产妇分娩镇痛效果、不良反应发生情况。2组初产妇分娩镇痛前、后不同时间点的体温、视觉模拟评分量表(VAS)评分比较，采用重复测量资料的方差分析。2组初产妇产时发热、寒战、低血压、恶心呕吐、瘙痒等不良反应发生率及总体不良反应发生率比较，采用χ²检验或者连续性校正χ²检验。本研究遵循的程序符合深圳市宝安区妇幼保健院人体试验委员会所制定的伦理学标准，得到该委员会批准(批准文号：QKTLL-2017-04-11)，分组征得受试者知情同意，并与其签署临床研究知情同意书。

①2组初产妇年龄、体重、分娩镇痛前宫口扩张情况、入院时体温等一般临床资料比较，差异均无统计学意义(P>0.05)。②观察组初产妇分娩镇痛起效时间为(11.0±1.3) min，显著短于对照组的(13.1±2.0) min，2组比较，差异有统计学意义(t＝6.559，P<0.001)。③观察组初产妇分娩镇痛前5 min及分娩镇痛后15、30 min的VAS评分分别为(9.30±0.42)分、(2.02±0.12)分、(1.16±0.13)分，对照组分别为(9.23±0.57)分、(23.15±0.38)分、(2.84±0.27)分，2组初产妇分娩镇痛前、后的VAS评分比较结果显示，处理措施与测定时间因素间存在交互作用(F_{处理×时间}＝32.187，P<0.001)。若固定测定时间因素，则2组初产妇分娩镇痛前5 min的VAS评分比较，差异无统计学意义(P>0.05)，而分娩镇痛后15、30 min，观察组VAS评分均显著低于对照组，差异均有统计学意义(t＝20.415、40.281，P<0.001)；若固定处理措施因素，则2组分娩镇痛前、后的VAS评分分别总体比较，差异均有统计学意义(F＝16.324、12.338，P<0.001)。④对2组初产妇分娩镇痛前、后的体温的比较结果显示，处理措施与测定时间因素间无交互作用(F_{处理×时间}＝0.699，P＝0.307)，初产妇分娩镇痛前5 min及分娩镇痛后1、2 h的体温比较，差异无统计学意义(F_时间＝0.287，P＝0.715)，2组初产妇体温比较，差异无统计学意义(F_处理＝0.365，P＝0.644)。⑤观察组寒战、低血压及总体不良反应发生率分别为1.9%(1/52)、3.8%(2/52)、15.4%(8/52)，分别显著低于对照组的16.0%(8/50)、18.0%(9/50)、50.0%(25/50)，2组比较，差异均有统计学意义(χ²＝4.651，P＝0.031；χ²＝5.307，P＝0.021；χ²＝13.956，P<0.001)。

初产妇分娩时，将局部麻醉药物预热至人体体温，可缩短分娩镇痛起效时间，提高分娩镇痛效果，并且可降低不良反应发生风险。

To explore the effects of local anesthetics with different temperatures on labor analgesia and adverse reactions of labor.

A total of 102 primiparae were selected from January 30, 2017 to January 10, 2018 in Shenzhen Baoan Maternal and Child Health Hospital. The 120 primiparae were randomly divided into two groups: observation group (n=52) and control group (n=50) by digits table method. The two groups were treated with continuous epidural anesthesia for labor analgesia, and the local anesthetics used in the two groups were the same, but the temperature of local anethetics were different. The local anesthetics in the control group were at room temperature (24 ℃), while the local anesthetics in the observation group were preheated to human body temperature (37 ℃). The analgesic effects and adverse reactions were observed in the two groups. The body temperatures and visual analogue scale (VAS) scores were compared at different time points before and after analgesia between the two groups by the variance analysis of repeated measurement data. Incidences of fever, chills, hypotension, nausea and vomiting, pruritus and total adverse reactions were compared by chi-square test or continuity correction of chi-square test. The procedures followed in this study was in accordance with the ethical standards established by the Human Beings Test Committee of Shenzhen Baoan District Maternal and Child Health Hospital, and was approved by the committee (Approval No. QKTLL-2017-04-11). And the clinical research informed consent form was signed with each primipara.

①There were no significant differences between two groups in the age, body weight, length of dilatation of cervix before analgesia and body temperature at admission (P>0.05). ②The onset time of analgesia in observation group was (11.0±1.3) min, which was obviously shorter than (13.1±2.0) min of control group, and the difference was statistically significant (t=6.559, P<0.001). ③The VAS scores of 5 min before analgesia and 15 min, 30 min after analgesia in observation group were (9.30±0.42) points, (2.02±0.12) points, and (1.16±0.13) points, respectively, and in control group were (9.23±0.57) points, (23.15±0.38) points, and (2.84±0.27) points, respectively. The compared results of VAS scores before and after analgesia between two groups showed that there was an interaction between the treatment measures and the time factor (F_{treatment×time}=32.187, P<0.001). The results of further analysis by fixing the time factor showed that there was no significant difference in the VAS score between the two groups 5 min before analgesia (P>0.05), while 15 and 30 min after analgesia, the VAS scores in the observation group both were significantly lower than those in the control group, and the differences were statistically significant (t=20.415, 40.281; P<0.001). And the results of further analysis by fixing the treatment measures factor showed that there were significant differences in VAS scores before and after analgesia both in the observation group and the control group (F=16.324, 12.338; P<0.001). ④ The compared results of body temperatures before and after analgesia showed that there was no interaction between the treatment measures and the time factor (F_{treatment×time}=0.699, P=0.307). There was no significant difference in body temperature at the time of 5 min before analgesia, 1 h and 2 h after analgesia (F _time=0.287, P=0.715). There was no significant difference in the body temperature between the two groups (F_treatment=0.365, P=0.644). ⑤The incidences of chill, hypotension and total adverse reactions in observation group were 1.9% (1/52), 3.8% (2/52), 15.4% (8/52) respectively, which were significantly lower than those in control group 16.0% (8/50), 18.0% (9/50), 50.0% (25/50), and all the differences were statistically significant (χ²=4.651, P=0.031; χ²=5.307, P=0.021; χ²=13.956, P<0.001).

Preheating local anesthetics to human body temperature during labor can shorten the onset time of analgesia, improve the analgesic effect, and reduce the risk of adverse reactions.