腹腔镜供肝切除术中腰后方肌阻滞与鞘内吗啡术后镇痛效果的比较:一项前瞻性随机非劣效性临床试验

Seungwon Lee, R. Kang, G. Kim, M. Gwak, G. Choi, J. M. Kim, J. Ko
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引用次数: 9

摘要

背景腰后方肌阻滞(QLB)和鞘内吗啡是腹腔镜肝切除术中公认的镇痛策略,但尚未比较其在腹腔镜供肝切除术后的效果。本研究计划进行这种比较。方法56例献血者随机接受双侧后路(QLB2,每侧0.375%罗哌卡因20 mL,共150 mg)或术前鞘内注射硫酸吗啡0.4 mg。主要终点为术后24小时静息疼痛评分。次要结局包括阿片类药物累积消耗和恢复参数。QLB组连续测定罗哌卡因血药浓度。只有结果评估者是正确的盲法。结果QLB组术后24小时静息疼痛评分平均为4.19±1.66 (n=27),鞘内吗啡组术后24小时静息疼痛评分平均为3.07±1.41 (n=27, p=0.04)。QLB组鞘内吗啡组的平均差异为1.11 (95% CI 0.27 ~ 1.95), CI上限高于预设的非劣效边际(δ=1),提示QLB效果较差。术后24小时和48小时,QLB组的阿片类药物累积消耗量显著增加。QLB组在所有时间点的术后瘙痒发生率均较低,其他恢复结果无差异。所有测量的罗哌卡因浓度均低于全身毒性阈值(4.3µg/mL)。结论双侧后路QLB在腹腔镜供肝切除术后24小时的静息疼痛评分高于鞘内吗啡,不符合非劣效性的定义。试验注册号为KCT0005360。
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Comparison of postoperative analgesic effects of posterior quadratus lumborum block and intrathecal morphine in laparoscopic donor hepatectomy: a prospective randomized non-inferiority clinical trial
Background Posterior quadratus lumborum block (QLB) and intrathecal morphine are accepted analgesic strategies in laparoscopic liver resection, but their effects have not been compared after laparoscopic donor hepatectomy. This study was planned to perform this comparison. Methods Fifty-six donors were randomized to receive bilateral posterior (QLB2, 20 mL of 0.375% ropivacaine on each side, 150 mg total) or preoperative injection of 0.4 mg morphine sulfate intrathecally. Primary outcome was resting pain score at 24 hour postsurgery. Secondary outcomes included cumulative opioid consumption and recovery parameters. Serial plasma ropivacaine concentrations were measured in QLB group. Only the outcome assessor was properly blinded. Results Mean resting pain score at 24-hour postsurgery was 4.19±1.66 in QLB group (n=27) and 3.07±1.41 in intrathecal morphine group (n=27, p=0.04). Mean difference (QLB group-intrathecal morphine group) was 1.11 (95% CI 0.27 to 1.95), and the upper limit of CI was higher than prespecified non-inferiority margin (δ=1), indicating an inferior effect of QLB. Cumulative opioid consumption was significantly higher in QLB group at 24 hours and 48 hours postsurgery. QLB group exhibited lower incidence of postoperative pruritus at all time points, and there were no differences in other recovery outcomes. All measured ropivacaine concentrations were below the threshold for systemic toxicity (4.3 µg/mL). Conclusions Bilateral posterior QLB elicited higher resting pain scores at 24-hour after laparoscopic donor hepatectomy than intrathecal morphine and did not meet the definition of non-inferiority. Trial registration number KCT0005360.
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