Maghsoudi Robab, Farhadi-Niaki Saeed, Etemadian Masoud, Kashi Amir H, Shadpour Pejman, Shirani Asemaneh, Samadinezhad-Khoshbaf-Sorkhabi Rana, Tabatabaei Meghdad
1 Hasheminejad Kidney Center, Iran University of Medical Sciences , Tehran, Iran .
2 Hasheminejad Kidney Center, Hospital Management Research Center, Iran University of Medical Sciences , Tehran, Iran .
J Endourol. 2018 Feb;32(2):168-174. doi: 10.1089/end.2017.0563. Epub 2018 Jan 26.
The purpose of this study was to compare the efficacy of tolterodine and gabapentin vs placebo in catheter related bladder discomfort (CRBD) following percutaneous nephrolithotomy (PCNL).
This study was a double-blind parallel group randomized clinical trial. Patients who were candidates of PCNL were enrolled. Patients were randomized to treatment groups of tolterodine 2 mg orally (PO) (group T, n = 50), gabapentin 600 mg PO (group G, n = 50), and placebo (group P, n = 70) 1 hour before operation using balanced block randomization. The primary endpoint of interest was visual analog pain scale in 1, 3, 12, and 24 hours after the operation. Secondary endpoints included rescue analgesic use (opioid and nonopioid).
The frequency of severe CRBD in 1,12, and 24 hours after the operation was 4%, 4%, and 6% in group T vs 4%, 0%, and 2% in group G vs 47%, 14%, and 6% in the P group (p < 0.001). The number of paracetamol injections for CRBD in the T and G groups was significantly lower than the placebo group (1.8 ± 0.8 vs 1.8 ± 0.7 vs 3.6 ± 0.7, p < 0.001). Likewise the number of pethidine injections in the T and G groups was significantly lower than the placebo group (0.42 ± 0.54 vs 0.68 ± 0.62 vs 2.4 ± 0.64, p < 0.001). In patients with history of Double-J insertion, the severity of CRBD was lower in all treatment groups.
Preoperative administration of oral tolterodine or gabapentin reduces postoperative CRBD and the need for rescue analgesics as much as 24 hours after surgery. Patients with history of Double-J insertion experience less CRBD.
本研究旨在比较托特罗定和加巴喷丁与安慰剂在经皮肾镜取石术（PCNL）后导管相关膀胱不适（CRBD）方面的疗效。
本研究为双盲平行组随机临床试验。纳入PCNL候选患者。采用均衡区组随机化方法，在手术前1小时将患者随机分为口服托特罗定2mg组（T组，n = 50）、口服加巴喷丁600mg组（G组，n = 50）和安慰剂组（P组，n = 70）。主要观察指标为术后1、3、12和24小时的视觉模拟疼痛评分。次要观察指标包括急救镇痛药的使用情况（阿片类和非阿片类）。
术后1、12和24小时，T组严重CRBD的发生率分别为4%、4%和6%，G组分别为4%、0%和2%，P组分别为47%、14%和6%（p < 0.001）。T组和G组因CRBD使用对乙酰氨基酚注射的次数显著低于安慰剂组（1.8±0.8 vs 1.8±0.7 vs 3.6±0.7，p < 0.001）。同样，T组和G组使用哌替啶注射的次数也显著低于安慰剂组（0.42±0.54 vs 0.68±0.62 vs 2.4±0.64，p < 0.001）。在有双J管置入史的患者中，所有治疗组的CRBD严重程度均较低。
术前口服托特罗定或加巴喷丁可降低术后CRBD，并减少术后24小时内急救镇痛药的使用需求。有双J管置入史的患者CRBD发生率较低。
