鞘内注射氢吗啡酮和吗啡用于剖宫产术后镇痛:采用序贯分配偏倚硬币法确定ED90

Intrathecal Hydromorphone and Morphine for Postcesarean Delivery Analgesia: Determination of the ED90 Using a Sequential Allocation Biased-Coin Method.

作者信息

Sviggum Hans P, Arendt Katherine W, Jacob Adam K, Niesen Adam D, Johnson Rebecca L, Schroeder Darrell R, Tien Michael, Mantilla Carlos B

机构信息

From the Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota.

出版信息

Anesth Analg. 2016 Sep;123(3):690-7. doi: 10.1213/ANE.0000000000001229.

Abstract

BACKGROUND

Intrathecal (IT) morphine is considered the "gold standard" for analgesia after cesarean delivery under spinal anesthesia, most commonly administered at a dose of 100 to 200 μg. There is less experience with IT hydromorphone for postcesarean analgesia and limited information on its optimal analgesic dose. We conducted this study to determine the effective analgesic dose for 90% patients (ED90) of IT hydromorphone that provides effective analgesia for women undergoing elective cesarean delivery and its potency ratio to IT morphine.

METHODS

In this dose-finding trial, 80 patients received spinal anesthesia for cesarean delivery. Participants were randomized to receive IT morphine or IT hydromorphone at a dose determined using up-down sequential allocation with a biased-coin design to determine ED90. All patients received standardized multimodal analgesia postoperatively in addition to IT opioid. An effective dose was defined as a numeric response score for pain of ≤3 (scale 0-10) 12 hours after spinal injection.

RESULTS

The ED90 was 75 μg (95% confidence interval [CI], 46-93 μg) for IT hydromorphone and 150 μg (95% CI, 145-185 μg) for IT morphine. At these doses, the 95% CI for the percentage of patients with effective analgesia (numeric rating scale ≤3) was 64% to 100% for hydromorphone and 68% to 100% for morphine. Exploratory findings showed that the incidence of nausea and pruritus was not different among the most commonly used doses of IT hydromorphone (P = 0.44 and P = 0.74) or IT morphine (P = 0.67 and P = 0.38, respectively). When administering IT opioids at ED90 doses or higher, 100% (21/21) of IT hydromorphone and 95% (37/39) of IT morphine patients were satisfied with their analgesia.

CONCLUSIONS

The ratio of IT morphine to IT hydromorphone for effective postcesarean analgesia is 2:1. Patient satisfaction was high with both medications.

摘要

背景

鞘内注射吗啡被认为是腰麻下剖宫产术后镇痛的“金标准”,最常用剂量为100至200μg。鞘内注射氢吗啡酮用于剖宫产术后镇痛的经验较少,其最佳镇痛剂量的信息有限。我们开展本研究以确定鞘内注射氢吗啡酮对90%接受择期剖宫产的女性有效的镇痛剂量(ED90)及其与鞘内注射吗啡的效价比。

方法

在这项剂量探索试验中,80例患者接受剖宫产腰麻。参与者被随机分配接受鞘内注射吗啡或鞘内注射氢吗啡酮,剂量通过采用偏倚硬币设计的上下序贯分配法确定,以确定ED90。除鞘内注射阿片类药物外,所有患者术后均接受标准化多模式镇痛。有效剂量定义为腰麻注射12小时后疼痛数字评分≤3(0 - 10分)。

结果

鞘内注射氢吗啡酮的ED90为75μg(95%置信区间[CI],46 - 93μg),鞘内注射吗啡的ED90为150μg(95%CI,145 - 185μg)。在这些剂量下,氢吗啡酮组有效镇痛(数字评分量表≤3)患者百分比的95%CI为64%至100%,吗啡组为68%至100%。探索性结果显示,最常用剂量的鞘内注射氢吗啡酮(P = 0.44和P = 0.74)或鞘内注射吗啡(分别为P = 0.67和P = 0.38)之间恶心和瘙痒的发生率无差异。以ED90剂量或更高剂量给予鞘内阿片类药物时,鞘内注射氢吗啡酮组100%(21/21)和鞘内注射吗啡组95%(37/39)的患者对镇痛效果满意。

结论

鞘内注射吗啡与鞘内注射氢吗啡酮用于剖宫产术后有效镇痛的效价比为2:1。两种药物的患者满意度均较高。

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