盐酸氯普鲁卡因联合布比卡因治疗择期混合痔切除术后尿潴留患者的临床研究

Clinical trial of chloropropane hydrochloride combined with bupivacaine in the treatment of patients with urinary retention after elective mixed hemorrhoids resection

目的 研究盐酸氯普鲁卡因联合低剂量布比卡因在择期混合痔切除术时氯普鲁卡因的最佳使用量,观察联合麻醉方案下尿潴留发生率。方法 前瞻性招募混合痔患者,用L3~L5蛛网膜下腔神经阻滞麻醉方式,第1例患者试验性应用3%盐酸氯普鲁卡因注射液3.0 mL缓慢推入,观察5 min后正式注入3%盐酸氯普鲁卡因6.0 mL,视觉模拟评分(VAS)≤2分时,第2例患者1/6概率接受较少剂量(下降1.0 mL)或5/6概率维持当前剂量;VAS>2分,第2例1/6概率接受较多剂量(增加1.0 mL)或5/6概率维持当前剂量。术前15 min注入盐酸布比卡因注射液0.1 mL(0.75 mg),注射速度:0.01 mL·s^(-1)。观察盐酸氯普鲁卡因的90%最大有效浓度(ED_(90))值、术后尿潴留发生率,观察盐酸氯普鲁卡因挽救剂量、术后15 d内镇痛效果VAS并进行安全性评价。Isotonic回归方程计算盐酸氯普鲁卡因ED_(90)、95%置信区间。结果 Isotonic回归方程提示盐酸氯普鲁卡因ED_(90)标注值为11.76 mL (95%CI:10.81,12.70);术后尿潴留总体发生率为19.18%(14例/73例),各初始用量组间尿潴留发生率差异有统计学意义(P<0.05)。初始剂量8.0~13.0 mL组、14.0~16.0 mL组、17.0~18.0 mL组尿潴留事件发生率分别为57.14%、0、42.86%;与同剂量组未发生尿潴留人群相比,14.0~16.0 mL组、17.0~18.0 mL组差异有统计学意义(P<0.05),8.0~13.0 mL组差异无统计学意义(P>0.05)。盐酸普鲁卡因挽救平均剂量为(13.44±1.57)mL,随初始剂量增加,盐酸氯普鲁卡因挽救剂量未见明显线性趋势(P>0.05)。在术后0、4、12、24 h的VAS分别为(1.55±0.90)、(6.55±0.44)、(2.95±0.93)和(1.78±0.69)分;术后4~24 h时间段内观察VAS呈现线性下降趋势(P>0.05)。本研究药物不良反应发生率为16.44%(12例/73例)。结论 在混合痔手术L3~L5蛛网膜下腔神经阻滞麻醉方式下,联用低剂量布比卡因时盐酸氯普鲁卡因ED_(90)为11.76 mL,组合麻醉方案可降低术后尿潴留发生率,减少麻醉挽救使用总剂量,药物不良发生率较低。

Objective To study the optimal amount of chloropropane combined with low-dose bupivacaine during elective mixed hemorrhoidectomy and to observe the incidence of urinary retention under the combined anesthetic regimen.Methods Prospectively recruited patients with mixed hemorrhoids,L3-L5 subarachnoid nerve block anesthesia was used,the first patient was experimentally applied 3%chloropropane hydrochloride injection 3.0 mL slowly pushed in,after5 min observation,3% chloropropane hydrochloride 6.0 mL was formally injected,when the visual analogue scale(VAS) was≤2,the second patient had 1/6 probability of receiving a lower dose(1.0 mL decrease) or 5/6probability of maintaining the current dose;when the VAS score was>2,the second case had a 1/6 probability of receiving a higher dose(1.0 mL increase) or a 5/6 probability of maintaining the current dose.The 90% effective dose(ED_(90)) value of chloropropane hydrochloride,the incidence of postoperative urinary retention,the saved dose of chloropropane hydrochloride,the VAS score of analgesic effect within 15 d after surgery,and the safety evaluation.Isotonic regression equation was used to calculate the ED_(90),95% confidence interval for chloroprocaine hydrochloride.Results The overall incidence of postoperative urinary retention was 19.18%(14 cases/73 cases),incidence of urinary retention between the initial dosage groups possessed statistical differences(P <0.05).The incidence of urinary retention were 57.14%,0 and 42.86% in 8.0-13.0 mL,14.0-16.0 mL and 17.0-18.0 mL groups,respectively;compared with the population without urinary retention in the same dose group,the 14.0-16.0 mL and17.0-18.0 mL had statistical difference(P<0.05),8.0-13.0 mL group did not have statistical difference(P> 0.05).The mean salvage dose was(13.44±1.57) mL,and no significant linear trend was seen in the salvage dose of chloropropane hydrochloride with increasing initial dose(P> 0.05).The VAS scores at 0,4,12 and 24 h postoperatively were 1.55±0.90,6.55±0.44,2.95±0.93 and 1.78±0.69,respectively;a linear decreasing trend in VAS scores was observed in the 4-24 h postoperative period(P> 0.05).The overall incidence of adverse drug reactions was 16.44%(12 cases/73 cases).Conclusion ED_(90) of chloropropane hydrochloride combined with lowdose bupivacaine anesthesia in L3-L5 subarachnoid nerve block anesthesia for mixed hemorrhoids surgery was 11.76mL.The combined anesthesia scheme can reduce the incidence of postoperative urinary retention and the total dose of anesthesia rescue.The incidence of adverse drug reactions is low and has certain clinical safety.