罗哌卡因联合地普司潘治疗开颅手术患者术后头皮局部浸润麻醉的镇痛效果和安全性：一项前瞻性随机对照试验

罗哌卡因联合地普司潘治疗开颅手术患者术后头皮局部浸润麻醉的镇痛效果和安全性：一项前瞻性随机对照试验

贵州医科大学     麻醉与心脏电生理课题组

翻译：安丽  编辑：张中伟  审核：曹莹

罂 粟 摘 要 

背景：预先注射局麻药可以预防切口部位的术后疼痛，但镇痛效果不足，维持时间较短。地普司潘是速效倍他米松磷酸钠和长效倍他米松二丙酸盐的组合。地普司潘作为局麻药的辅助剂是否能减轻开颅术后的疼痛尚未研究。

方法：这是一项前瞻性、单中心、盲法、随机、对照临床研究，纳入年龄为18岁至64岁的患者，美国麻醉师协会（ASA）的身体状况分级为I至III，予择期行幕上开颅手术。我们筛选了2019年9月3日至2020年8月15日的患者。最后的后续工作于2021年2月15日完成。符合条件的患者被随机分配到地普司潘组(48例)或对照组(48例)，地普司潘组接受0.5%罗哌卡因加地普司潘的切口浸润麻醉治疗，对照组接受0.5%罗哌卡因（n=48）， 分配比例为1:1。主要结果是在48小时内患者自控镇痛（PCA）累积舒芬太尼（μg）的用量，并在手术后数小时内，根据患者意向治疗原则进行初步分析。

结果：两组患者之间的基线特征无显著差异（P>0.05）。在地普司潘组术后48小时内PCA累积舒芬太尼用量为5 (0-16)µg，显著低于对照组（38【30.5–46】µg；P<0.001）。

结论：罗哌卡因联合地普司潘的局部浸润麻醉可使开颅术后疼痛得到满意的缓解；这是一种简单、易行、安全，值得临床推广的技术。

原始文献来源： 

Xueye Han, MD,Tong Ren, MD,Yang Wang, MD, Nan Ji, MD, and Fang Luo,MD.Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial.Anesth Analg 2022 Mar 1.DOI：10.1213/ANE.0000000000005971.

英文原文

Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial

Abstract

Background Preemptive injection of local anesthetics can prevent postoperative pain at the incision site, but the analgesic effect is insufficient and is maintained only for a relatively short period of time. Diprospan is a combination of quick-acting betamethasone sodium phosphate and long-acting betamethasone dipropionate. Whether Diprospan as an adjuvant to local anesthetic can achieve postcraniotomy pain relief has not been studied yet.

Methods  This is a prospective, single-center, blinded, randomized, controlled clinical study, which included patients ages 18 and 64 years, with American Society of Anaesthesiologists (ASA) physical statuses of I to III, scheduled for elective supratentorial craniotomy. We screened patients for enrollment from September 3, 2019, to August 15, 2020. The final follow-up was completed on February 15, 2021. Eligible patients were randomly assigned to either the Diprospan group, who received incision-site infiltration of 0.5% ropivacaine plus Diprospan (n = 48), or the control group, who received 0.5% ropivacaine alone (n = 48), with a distribution ratio of 1:1. Primary outcome was the cumulative sufentanil (μg) consumption through patient-controlled analgesia (PCA) within 48 hours after surgery. Primary analysis was performed based on the intention-to-treat (ITT) principle.

Results  Baseline characteristics were not significantly different between the 2 groups (P > .05). In the Diprospan group, the cumulative sufentanil consumption through PCA was 5 (0–16) µg within 48 hours postoperatively, which was significantly lower than that in the control group (38 [30.5–46] µg; P < .001).

Conclusion Infiltration of ropivacaine and Diprospan can achieve satisfactory postoperative pain relief after craniotomy; it is a simple, easy, and safe technique, worth clinical promotion.