Zhao Chunmei, Wang Shaoheng, Pan Yuesong, Ji Nan, Luo Fang
Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.
J Pain Res. 2021 Apr 19;14:1071-1082. doi: 10.2147/JPR.S300943. eCollection 2021.
Incision-site infiltration with local anesthetics prevents pain on incision site, but pain relief is limited to the first few postoperative hours. Dexamethasone as an adjuvant to local infiltration successfully achieves better postoperative pain relief; however, this has not been studied in craniotomy patients yet.
This is a prospective, single-center, blinded, randomized, controlled trial included patients aged between 18 and 64 years, ASA physical status of I-II, scheduled for elective supratentorial tumor craniotomy under general anesthesia. We screened patients for enrollment from April 4, 2019 through August 15, 2019. The final study visit of the last patient was conducted on February 13, 2020. We randomly assigned eligible participants (1:1) to either the dexamethasone group who received incision-site infiltration of 0.5% ropivacaine plus 0.033% dexamethasone (N=70) or the control group who received 0.5% ropivacaine alone (N=70). Primary outcome was the cumulative sufentanil consumption (μg) within 48 hours postoperatively. Primary analysis was performed based on the modified intention-to-treat (MITT) principle.
Baseline characteristics were similar between the groups (p>0.05). Sufentanil consumption during the first 48 hours postoperatively was 29.0 (10.7) μg in the dexamethasone group and 38.3 (13.7) μg in the control group (mean difference -9.3, 95% CI -13.4 to -5.1; p<0.001). There was no serious adverse effect directly associated with incision-site infiltration or local dexamethasone use.
The addition of dexamethasone to pre-emptive incision-site infiltration with the local anesthetic can reduce about 27% of opioids consumption and the postoperative pain scores within 72 hours after craniotomy.
ClinicalTrials.Gov (NCT03618264).
局部麻醉药切口部位浸润可预防切口部位疼痛，但疼痛缓解仅限于术后最初几个小时。地塞米松作为局部浸润的辅助药物可成功实现更好的术后疼痛缓解；然而，这在开颅手术患者中尚未得到研究。
这是一项前瞻性、单中心、双盲、随机对照试验，纳入年龄在18至64岁之间、美国麻醉医师协会（ASA）身体状况为I-II级、计划在全身麻醉下进行择期幕上肿瘤开颅手术的患者。我们从2019年4月4日至2019年8月15日筛选患者进行入组。最后一名患者的最终研究访视于2020年2月13日进行。我们将符合条件的参与者（1:1）随机分配至地塞米松组，该组接受0.5%罗哌卡因加0.033%地塞米松的切口部位浸润（N = 70），或对照组，该组仅接受0.5%罗哌卡因（N = 70）。主要结局是术后48小时内舒芬太尼的累积消耗量（μg）。主要分析基于改良意向性治疗（MITT）原则进行。
两组间基线特征相似（p>0.05）。地塞米松组术后前48小时舒芬太尼消耗量为29.0（10.7）μg，对照组为38.3（13.7）μg（平均差值 -9.3，95%CI -13.4至 -5.1；p<0.001）。没有与切口部位浸润或局部使用地塞米松直接相关的严重不良反应。
在局部麻醉药预防性切口部位浸润中添加地塞米松可减少开颅术后72小时内约27%的阿片类药物消耗量和术后疼痛评分。
ClinicalTrials.Gov（NCT03618264）。
