Niklasson Boel, Arnelo Catarina, Öhman Susanne Georgsson, Segerdahl Märta, Blanck Agneta
Department of Clinical Science, Intervention and Technology (CLINTEC), Division of Obstetrics and Gynecology, Karolinska Institute at the Karolinska University Hospital, Huddinge, 141 86 Stockholm, Sweden.
Sophiahemmet University, Box 5605, 114 86 Stockholm, Sweden.
Scand J Pain. 2015 Apr 1;7(1):17-24. doi: 10.1016/j.sjpain.2015.01.003.
Background and aims The present randomized open label parallel group study was conducted to evaluate if an oral oxycodone (OXY) regimen can be at least equally effective and as safe for postoperative analgesia after caesarean section (CS) as a standard of care program using nurse-administered intravenous morphine (IVM), followed by oral codeine. Methods Eighty women (40 + 40) were scheduled for elective CS under spinal anaesthesia. All patients received postoperative multimodal analgesic therapy, including ibuprofen and paracetamol. The OXY group got standardized extended release and short acting oral treatment (and in a few cases intravenous OXY) as needed and the other group received current standard of care, IVM as needed for 24 h, followed by codeine. Opioid treatment lasted maximum five days. Outcome measures were pain intensity (numerical rating scale, NRS), opioid requirements, duration of administering opioids and safety for mother and newborn. All opioids in the study were expressed in OXY equivalents, using a conversion table. As the bioavailability of each opioid has a certain extent of interindividual bioavailability this conversion represents an approximation. The possible influence of opioids on the newborns was evaluated by the Neurological Adaptive Capacity Score at birth and at 24 and 48 h. Results During the first 24 h, there were no differences between treatments in opioid requirements or mean pain intensity at rest but pain intensity when asking for rescue medication was lower in the OXY than in the IVM group (mean ± SD; 5.41 ± 6.42 vs. 6.42 ± 1.61; p = 0.027). Provoked pain (uterus palpation) during the first 6h was also less in the OXY group (3.26 ± 2.13 vs. 4.60 ± 2.10; p = 0.007). During the 25-48 h period postoperatively, patients on OXY reported significantly lower pain intensity at rest (2.9 ± 1.9 vs. 3.8 ± 1.8; p = 0.039) and consumed less opioids (OXY equivalents; mg) (31.5 ± 9.6 vs. 38.2 ± 38.2; p = 0.001) than those on IVM/codeine. The total amount of opioids 0-5 days postoperatively was significantly lower in the OXY than in the IVM/codeine group (108.7 ± 37.6 vs. 138.2 ± 45.1; p = 0.002). Duration of administering opioids was significantly shorter in the OXY group. Time to first spontaneous bowel movement was shorter in the OXY group compared with the IVM/codeine group. No serious adverse events were recorded in the mothers but the total number of common opioid adverse effects was higher among women on IVM/codeine than among those receiving OXY (15 vs. 3; p = 0.007). No adverse outcomes in the newborns related to treatment were observed in either group. Conclusions In a multimodal protocol for postoperative analgesia after CS better pain control and lower opioid intake was observed in patients receiving oral OXY as compared to those on IVM/codeine. No safety risks for mother and child were identified with either protocol. Implications Our findings support the view that use of oral OXY is a simple, effective and time saving treatment for postoperative pain after CS.
开展本随机开放标签平行组研究,旨在评估口服羟考酮(OXY)方案用于剖宫产(CS)术后镇痛时,是否至少与使用护士给予静脉注射吗啡(IVM)并继以口服可待因的标准护理方案同样有效且安全。方法:80名女性(40 + 40)计划在腰麻下行择期剖宫产。所有患者均接受术后多模式镇痛治疗,包括布洛芬和对乙酰氨基酚。OXY组根据需要接受标准化缓释和短效口服治疗(少数情况下为静脉注射OXY),另一组接受当前标准护理,按需静脉注射IVM 24小时,随后给予可待因。阿片类药物治疗最长持续5天。观察指标为疼痛强度(数字评分量表,NRS)、阿片类药物需求量、阿片类药物给药持续时间以及对母婴的安全性。研究中的所有阿片类药物均使用换算表以OXY等效量表示。由于每种阿片类药物的生物利用度存在一定程度的个体间差异,这种换算只是一个近似值。通过出生时及出生后24小时和48小时的神经适应性能力评分评估阿片类药物对新生儿的可能影响。结果:在最初24小时内,治疗组之间在阿片类药物需求量或静息时的平均疼痛强度方面无差异,但在需要急救药物时,OXY组的疼痛强度低于IVM组(均值±标准差;5.41±6.42 vs. 6.42±1.61;p = 0.027)。OXY组在最初6小时内诱发疼痛(子宫触诊)也较轻(3.26±2.13 vs. 4.60±2.10;p = 0.007)。在术后25 - 48小时期间,与接受IVM/可待因的患者相比,接受OXY治疗的患者静息时疼痛强度显著更低(2.9±1.9 vs. 3.8±1.8;p = 0.039)且阿片类药物消耗量更少(OXY等效量;mg)(31.5±9.6 vs. 38.2±38.2;p = 0.001)。术后0 - 5天阿片类药物总量在OXY组显著低于IVM/可待因组(108.7±37.6 vs. 138.2±45.1;p = 0.002)。OXY组阿片类药物给药持续时间显著更短。与IVM/可待因组相比,OXY组首次自主排便时间更短。母亲中未记录到严重不良事件,但接受IVM/可待因的女性中常见阿片类药物不良反应总数高于接受OXY的女性(15例 vs. 3例;p = 0.007)。两组均未观察到与治疗相关的新生儿不良结局。结论:在剖宫产术后多模式镇痛方案中,与接受IVM/可待因的患者相比,接受口服OXY的患者疼痛控制更好且阿片类药物摄入量更低。两种方案均未发现对母婴的安全风险。意义:我们的研究结果支持以下观点,即口服OXY是一种用于剖宫产术后疼痛的简单、有效且节省时间的治疗方法。