切换至 "中华医学电子期刊资源库"

中华疝和腹壁外科杂志(电子版) ›› 2025, Vol. 19 ›› Issue (06) : 645 -651. doi: 10.3877/cma.j.issn.1674-392X.2025.06.008

论著

布比卡因脂质体用于Lichtenstein术后镇痛效果及安全性分析:一项单中心随机对照试验
王宏1,2,3, 董国强1,2,3, 刘韦鋆1,2,3, 张楠1,2,3,()   
  1. 1300100 天津市南开医院胃肠外科二
    2300100 天津市中西医结合急腹症研究所
    3300100 天津市急腹症器官损伤与中西医修复重点实验室
  • 收稿日期:2025-04-16 出版日期:2025-12-18
  • 通信作者: 张楠
  • 基金资助:
    天津市中西医结合医院天津市南开医院临床研究项目(NKYY-GLWYH-IIT-YW-2024-012); 天津市医学重点学科建设项目(TJYXZDXK-3-028C)

Analysis of postoperative analgesic efficacy and safety of liposomal bupivacaine in Lichtenstein surgery: A single-center randomized controlled trial

Hong Wang1,2,3, Guoqiang Dong1,2,3, Weijun Liu1,2,3, Nan Zhang1,2,3,()   

  1. 1Second Department of Gastrointestinal Surgery, Tianjin NanKai Hospital, Tianjin 300100, China
    2Tianjin Institute of Integrative Medicine for Acute Abdominal Diseases, Tianjin 300100, China
    3Tianjin Key Laboratory of Acute Abdomen Disease Associated Organ Injury and ITCWM Repair, Tianjin 300100, China
  • Received:2025-04-16 Published:2025-12-18
  • Corresponding author: Nan Zhang
引用本文:

王宏, 董国强, 刘韦鋆, 张楠. 布比卡因脂质体用于Lichtenstein术后镇痛效果及安全性分析:一项单中心随机对照试验[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(06): 645-651.

Hong Wang, Guoqiang Dong, Weijun Liu, Nan Zhang. Analysis of postoperative analgesic efficacy and safety of liposomal bupivacaine in Lichtenstein surgery: A single-center randomized controlled trial[J/OL]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2025, 19(06): 645-651.

目的

探讨布比卡因脂质体在超声引导下腹横肌平面阻滞(TAPB)中对开放无张力腹股沟疝修补术(Lichtenstein术)术后镇痛的有效性及安全性。

方法

采用前瞻性、单中心、随机、双盲、阳性对照临床试验,将2024年5月至2025年3月于天津市南开医院胃肠外科二行单侧Lichtenstein手术的患者82例,采用区组随机化方法分为A组(灭菌注射用水20 ml)、B组(7.5 mg/ml盐酸布比卡因10 ml+生理盐水10 ml)、C组(13.3 mg/ml布比卡因脂质体10 ml+灭菌注射用水10 ml)。术后第1、2、3、4、5、6、8、10、12、24、36、48、72和96 h 14次评估患者的静息疼痛(采用数字评定量表法)并绘制疼痛曲线,比较术后0~96 h疼痛评分的累积负担[曲线下面积(AUC)]、阿片类药物用量及不良反应发生情况。

结果

3组患者术前一般资料比较,差异均无统计学意义(P>0.05)。C组AUC(172.18)显著小于A组(233.42,P<0.001)及B组(228.90,P<0.001),而A、B组间AUC差异无统计学意义(P=0.752)。3组患者中C组补偿用药率最低,差异有统计学意义(P<0.05),C组首次补偿用药时间显著长于A组、B组,C组术后疼痛控制效果更优,无需补偿用药的比例更高。3组患者术后镇痛的不良反应发生情况比较,差异无统计学意义(P>0.05)。

结论

术前采用布比卡因脂质体行超声引导下TAPB可有效缓解开放无张力疝修补术后疼痛,效果优于传统布比卡因,且安全性相当。

Objective

To evaluate the efficacy and safety of liposomal bupivacaine for postoperative analgesia in patients undergoing open tension-free inguinal herniorrhaphy (Lichtenstein repair) via ultrasound-guided transversus abdominis plane block (TAPB).

Methods

A prospective, single-center, randomized, double-blind, positive-controlled clinical trial was conducted. Eighty-two patients scheduled for unilateral Lichtenstein herniorrhaphy in the Second Department of Gastrointestinal Surgery, Tianjin Nankai Hospital between May 2024 and March 2025 were enrolled. Using block randomization, patients were assigned to one of three groups: Group A (20 ml sterile water for injection), Group B (10 ml 7.5 mg/ml hydrochloride bupivacaine+10 ml normal saline), and Group C (10 ml 13.3 mg/ml liposomal bupivacaine+ 10 ml sterile water for injection ). Resting pain scores (using the numeric rating scale method) were assessed 14 times at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours postoperatively, and pain profiles were plotted. The cumulative burden of pain scores [area under the curve (AUC)], opioid drugs consumption, and incidence of adverse reactions during the 0-96-hour postoperative period were compared.

Results

No statistically significant differences were observed in preoperative general characteristics among the three groups (P>0.05). The AUC in Group C (172.18) was significantly lower than that in Group A (233.42, P<0.001) and Group B (228.90, P<0.001), whereas no significant difference was found between Group A and Group B (P=0.752). Among the three groups of patients, Group C had the lowest rescue medication rate, with a statistically significant difference (P<0.05). The time to first rescue medication in Group C was significantly longer than that in Groups A and B. Group C had better postoperative pain control effect, and a higher proportion of patients did not require rescue medication. The incidence of postoperative analgesic-related adverse events has no significant difference among the three groups (P>0.05).

Conclusion

Preoperative administration of liposomal bupivacaine under ultrasound- guided TAPB effectively alleviates pain after open tension-free herniorrhaphy, with superior efficacy compared to conventional bupivacaine and a comparable safety profile.

图1 受试对象流程图
表1 3组患者的一般资料比较
图2 3组患者术后累积疼痛强度评分(NRS AUC 0~96 h)注:NRS为数字评分量表(0分=无痛,10分=最剧烈疼痛),AUC为0~96 h疼痛评分的累积总和。
表2 3组患者术中局部麻醉药用量比较
表3 3组患者术后0~96 h补偿用药率比较
图3 3组患者术后0~96 h第一次补偿用药时间
表4 3组患者术后镇痛不良反应发生情况比较[例(%)]
[1]
Aiolfi A, Cavalli M, Ferraro SD, et al. Treatment of Inguinal Hernia: Systematic Review and Updated Network Meta-analysis of Randomized Controlled Trials[J]. Ann Surg, 2021, 274(6): 954-961.
[2]
黄翠景, 吴永丰, 刘兴洲. 无张力疝修补术与腹腔镜全腹膜外疝修补术治疗老年腹股沟疝的临床效果及安全性评价[J]. 中国医刊, 2021, 56(4): 439-442.
[3]
马贞华, 邓婧, 田文瀚, 等. 盐酸羟考酮剂量选择对腹横肌平面神经阻滞腹股沟疝修补术患者镇痛效果的影响[J]. 中国医刊, 2021, 56(4): 451-453.
[4]
王桐生, 丁磊, 李稳霞, 等. 腹腔镜腹股沟疝无张力修补术后并发缺血性睾丸炎风险预测列线图的建立及验证[J]. 中国医刊, 2021, 56(11): 1229-1233.
[5]
唐健雄, 李航宇. 老年腹股沟疝诊断和治疗中国专家共识(2019版)解读[J]. 临床外科杂志, 2020, 28(1): 12-15.
[6]
贾晓童, 武广函, 吕蒙, 等. 腰方肌阻滞与肋缘下腹横肌平面阻滞在腹腔镜胃癌根治术后镇痛效果的比较[J]. 国际麻醉学与复苏杂志, 2022, 43(3): 252-257.
[7]
李东明, 杨鋆, 王宇凡, 等. 腹腔镜辅助腹横肌平面阻滞技术临床应用进展[J]. 中国实用外科杂志, 2021, 41(4): 469-471.
[8]
邓先锐, 郑磊, 徐通海, 等. 日间手术模式在腹股沟疝修补术中的应用价值[J]. 中华消化外科杂志, 2023, 22(9): 1075-1079.
[9]
王小平, 舒海华, 黄雪花, 等. 腹横肌平面阻滞中国疼痛学与麻醉学专家共识(2023版)[J]. 中华疼痛学杂志, 2023, 19(2): 184-201.
[10]
Long X, Yin Y, Guo W, et al. Ultrasound-guided quadratus lumborum block: a powerful way for reducing postoperative pain[J]. Ann Med Surg (Lond), 2023, 85(10): 4947-4953.
[11]
Dai L, Ling X, Qian Y. Effect of Ultrasound-Guided Transversus Abdominis Plane Block Combined with Patient-Controlled Intravenous Analgesia on Postoperative Analgesia After Laparoscopic Cholecystectomy: a Double-Blind, Randomized Controlled Trial[J]. J Gastrointest Surg, 2022, 26(12): 2542-2550.
[12]
陈斌, 马晗, 赵彦礼, 等. 局麻联合超声引导下腹横肌平面(TAP)阻滞技术在老年腹股沟疝中的应用[C]//中国生命关怀协会.关爱生命大讲堂之生命关怀与智慧康养系列学术研讨会论文集(中)——银发浪潮下老年护理的挑战与机遇专题. 阿克苏: 新疆生产建设兵团第一师医院, 2025: 142-144.
[13]
叶庆遥, 田甜, 唐朝亮, 等. 超声引导下连续腹横肌平面阻滞对开腹直肠癌根治术患者术后早期恢复质量的影响[J]. 临床麻醉学杂志, 2019, 35(8): 779-782.
[14]
Liu DX, Zhu ZQ. Ultrasound-guided peripheral trunk block technique: A new approach gradually stepping onto the stage of clinical anesthesia[J]. Ibrain, 2021, 7(3): 211-226.
[15]
Yeoh SR, Chou Y, Chan SM, et al. Pericapsular Nerve Group Block and Iliopsoas Plane Block: A Scoping Review of Quadriceps Weakness after Two Proclaimed Motor-Sparing Hip Blocks[J]. Healthcare (Basel), 2022, 10(8): 1565.
[16]
Ilfeld BM, Eisenach JC, Gabriel RA. Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain[J]. Anesthesiology, 2021, 134(2): 283-344.
[17]
Cui J, Xu Q, Yu Z, et al. Local infiltration of HYR-PB21, a sustained-release formulation of bupivacaine, provides analgesia and reduces opioid requirement after haemorrhoidectomy: a randomised controlled trial[J]. Br J Anaesth, 2022, 129(6): 970-976.
[18]
Feierman DE, Kim J, Bronstein A, et al. The use of bilateral transversus abdominis plane blocks with liposomal bupivacaine on postoperative cesarean delivery patients during COVID-19 pandemic is associated with reduced narcotics use and reduced length of stay[J]. Womens Health (Lond), 2021, 17: 17455065211058046.
[19]
Schwartz G, Gadsden JC, Gonzales J, et al. A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy[J]. J Clin Anesth, 2024, 94: 111402.
[20]
罗婧予, 吴红, 陈刚, 等. 布比卡因脂质体用于臂丛阻滞对肩袖修补术后镇痛及膈肌收缩功能的影响[J]. 中国临床药理学与治疗学, 2025, 30 (5): 665 -672.
[21]
Cheung BM, Ng PY, Liu Y, et al. Pharmacokinetics and safety of liposomal bupivacaine after local infiltration in healthy Chinese adults: a phase 1 study[J]. BMC Anesthesiol, 2021, 21(1): 197.
[1] 李涛, 朱含放, 李世拥. 我国腹腔镜疝修补术式选择与原则[J/OL]. 中华普外科手术学杂志(电子版), 2025, 19(04): 362-365.
[2] 李涛, 朱含放, 李世拥. 腹腔镜下经腹腹膜前右侧腹股沟疝修补术[J/OL]. 中华普外科手术学杂志(电子版), 2025, 19(04): 366-366.
[3] 陈双, 李英儒. 单孔腹腔镜腹股沟疝经腹腹膜前修补术的技术与方法[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(06): 629-632.
[4] 彭鹏, 陈杰. 机器人手术在疝和腹壁外科领域国内外应用现状及展望[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(06): 638-644.
[5] 徐安军, 覃炳志, 吴德俊, 王一豪, 赵杰炳, 李诗媛, 王廷峰. 新型生物补片在污染/感染性腹股沟疝经腹腹膜前修补术中的应用[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 505-510.
[6] 常帅, 赵耀, 张迪, 李顺乐, 翟宏军, 吉鸿. 腹腔镜经腹腹膜前修补术与腹腔镜腹腔内补片修补术治疗脐疝的对比研究[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 529-534.
[7] 邱忠伟, 陈坤, 唐成, 许超, 向青锋. 腹腔镜经腹腹膜前疝修补术在腹股沟嵌顿疝手术中的应用[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 544-546.
[8] 郑小龙, 李挺, 隋永健, 徐辉. 疝囊进入阴囊的腹股沟直疝CT表现[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 559-562.
[9] 王珺, 黄敏. 舒适护理联合大黄芒硝外敷对腹股沟疝术后阴囊水肿的临床疗效观察[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 567-570.
[10] 刘德琦, 刘姗, 袁浩然, 王雯璇, 彭新刚. 疝补片材料研究进展[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 582-588.
[11] 赵敏娴, 李海云, 杨慧琪. 基于成果导向教育理念的三阶段式腹腔镜食管裂孔疝修补术教学在进修医师培训中的实践[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 589-594.
[12] 靳翠红, 申英末, 储诚兵. 腹腔镜手术模拟器在腹腔镜下经腹腹膜前疝修补术教学培训中的应用[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 595-598.
[13] 张兴洲, 魏明, 董国强, 张楠. 切口疝修补术后补片感染并发肠瘘及疝复发一例临床分析[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 599-601.
[14] 陆进, 周世勇, 艾飞, 石若飞, 付安迪, 杨鑫. 双侧腹股沟疝合并隐睾患者一例临床分析[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(05): 602-604.
[15] 罗彬予, 柏丹, 滕庆, 郭炜, 黄斌, 田云鸿. 基于倾向评分匹配评价70岁及以上患者在日间手术模式下行腹股沟疝修补术的安全性及可行性分析[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(04): 427-433.
阅读次数
全文


摘要


AI


AI小编
你好!我是《中华医学电子期刊资源库》AI小编,有什么可以帮您的吗?