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阴部神经阻滞对经尿道前列腺切除术术后膀胱相关并发症的影响研究
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注册号：

Registration number：

 ChiCTR2200058372 

最近更新日期：

Date of Last Refreshed on：

 2022-12-10 15:00:33 

注册时间：

Date of Registration：

 2022-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阴部神经阻滞对经尿道前列腺切除术术后膀胱相关并发症的影响研究

Public title：

The effect of pudendal nerve block on bladder-related complications after transurethral prostatectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阴部神经阻滞对经尿道前列腺切除术术后膀胱相关并发症的影响研究

Scientific title：

The effect of pudendal nerve block on bladder-related complications after transurethral prostatectomy

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

王升艳 

研究负责人：

沈徐 

Applicant：

Wangshengyan 

Study leader：

Shenxu 

申请注册联系人电话：

Applicant telephone：

 +86 17205881127

研究负责人电话：

Study leader's
telephone：

+86 13957306365

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 2605181789@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 fishsx0321@sina.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

浙江省嘉兴市南湖区中环南路1882号

研究负责人通讯地址：

浙江省嘉兴市南湖区中环南路1882号

Applicant address：

1882, Zhonghuan South Road, Nanhu District, Jiaxing, Zhejiang

Study leader's address：

1882, Zhonghuan South Road, Nanhu District, Jiaxing, Zhejiang

申请注册联系人邮政编码：

Applicant postcode：

 314001

研究负责人邮政编码：

Study leader's postcode：

 314001

申请人所在单位：

嘉兴市第一医院

Applicant's institution：

Jiaxing First Hospital

研究负责人所在单位：

嘉兴市第一医院

Affiliation of the Leader：

Jiaxing First Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 LS2021-KY-045

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

嘉兴市第一医院伦理委员会

Name of the ethic committee：

Jiaxing First Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-05-17 00:00:00

伦理委员会联系人：

浦以凤

Contact Name of the ethic committee：

Puyifeng

伦理委员会联系地址：

浙江省嘉兴市南湖区中环南路1882号

Contact Address of the ethic committee：

1882, Zhonghuan South Road, Nanhu District, Jiaxing, Zhejiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

 13967360920

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 jxsdyyykjk@163.com

研究实施负责（组长）单位：

嘉兴市第一医院

Primary sponsor：

Jiaxing First Hospital

研究实施负责（组长）单位地址：

浙江省嘉兴市南湖区中环南路1882号

Primary sponsor's address：

1882, Zhonghuan South Road, Nanhu District, Jiaxing, Zhejiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

嘉兴

Country：

China

Province：

Zhejiang

City：

Jiaxing

单位(医院)：

嘉兴市第一医院

具体地址：

浙江省嘉兴市南湖区中环南路1882号

Institution
hospital：

Jiaxing First Hospital

Address：

1882, Zhonghuan South Road, Nanhu District, Jiaxing, Zhejiang

经费或物资来源：

嘉兴市第一医院

Source(s) of funding：

Jiaxing First Hospital

研究疾病：

导尿管相关膀胱不适 膀胱痉挛  

Target disease：

Catheter related bladder discomfort bladder spasm

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

观察和比较全身麻醉复合超声引导下阴部神经阻滞模式和常规全身麻醉模式下两组患者术后导管相关膀胱不适和膀胱痉挛总发生率，围术期镇痛药物使用量，术后VAS评分。探讨经阴部管水平阴部神经阻滞对经尿道前列腺切除术患者术后膀胱相关并发症的预防及治疗。  

Objectives of Study：

The total incidence of postoperative catheter-related bladder discomfort and bladder spasm, the amount of analgesic drugs used during the perioperative period, and the postoperative VAS score were observed and compared between the two groups of patients under general anesthesia combined with ultrasound-guided pudendal nerve block mode and conventional general anesthesia mode. To investigate the prevention and treatment of bladder-related complications after transurethral resection of the prostate by transpudendal nerve block at the level of the pudendal canal.

药物成份或治疗方案详述：

单侧0.3％罗哌卡因（耐乐品）10ml 所有患者均不给予术前用药，入室后开放外周静脉通路，监测ECG、BP、HR、SpO2、BIS。A组，选用凸阵探头，耦合剂涂抹探头并做无菌处理，穿刺前适当镇静、镇痛。患者取侧卧位，屈髋屈膝，阻滞侧向上。采用矢状面定位技术，把探头放置于骼后上棘与股骨大转子连线的中点，探头长轴与连线平行，超声可识别出一条连续的高回声线，即髋骨线，并且可以看到臀上动脉在臀中肌深处搏动。将探头向尾端及内侧移动，直到髋骨的连续高回声线断裂，即骶骨旁平行移动技术。然后超声束与较大的坐骨切迹相交，将探头沿坐骨大切迹的侧缘进一步向远侧平行移动至坐骨棘，在坐骨棘近端，阴部动脉和臀下动脉从梨状肌下缘的骨盆发出，当超声束与坐骨棘相交时，再次出现高回声影，此为骶棘韧带和骶结节韧带。阴部神经、臀下神经和坐骨神经以及阴部内动脉和臀下动脉通常在骶棘韧带和骶结节韧带之间的坐骨棘尖端周围靠得很近。当探头平行移动到坐骨棘尾部时，到达较小的坐骨切迹，该切迹光滑且呈圆形，内部闭孔肌腱围绕其缠绕。将探头沿坐骨小切迹平行移动到更远侧，在尾骨和闭孔内肌之间的锐角处，在阴部管的近端部分可以看到阴部神经、动脉和静脉。采用平面内进针技术，将一次性无菌穿刺针，从探头的内侧端插入平面内并推进直到针尖靠近阴部神经。从内侧进针可避免针头接触坐骨结节，并尽量减少直肠穿孔的风险。穿刺针穿过骶结节韧带时有明显落空感，当针头靠近阴部神经时，回抽无血，缓慢注射0.3％罗哌卡因共10ml并间断回抽，可见局麻药液在骶棘韧带、骶结节韧带及阴部内动脉之间呈梭形扩散，视扩散情况调整针尖位置。采用体表针刺法测定阻滞平面，感觉阻滞起效时，会阴部及肛门部开始麻木，针刺无痛觉，再嘱患者做提肛运动，肛门无收缩动作，表示阻滞完全。阻滞完一侧后改变体位阻滞另一侧。明确阻滞完全后，进行麻醉诱导，依次缓慢静脉注射依托咪酯0.2-0.4mg/kg，顺式阿曲库铵0.2mg/kg，芬太尼4μg/kg，面罩加压给氧去氮4.5min后行气管内插管，设定通气参数为潮气量8ml/kg，呼吸频率10-12次/分，吸呼比1：2，呼气末二氧化碳分压（PETCO2）维持在35-45mmHg(1mmHg=0.133kPa)，氧流量2L/min。麻醉维持：吸入七氟烷，维持最低肺泡有效浓度（MAC）在1.0，泵注盐酸右美托咪定0.5ug·kg-1·h-1、瑞芬太尼0.1～0.2ug·kg-1·h-1、异丙酚4～6mg·kg-1·h-1，每间隔40-50min静脉注射顺式阿曲库铵0.05mg/kg维持肌松。术中维持BIS值在40-60，均采用输液加温仪进行输液，保温毯维持体温在36-37℃。 

Description for medicine or protocol of treatment in detail：

All patients were not given preoperative medication. After entering the room, peripheral venous access was opened to monitor ECG, BP, HR, SpO2, and BIS. In group A, a convex array probe was used, and the probe was smeared with couplant and treated aseptically. The patient is placed in a lateral decubitus position, with the hips and knees flexed, and the block side up. Using the sagittal plane positioning technique, place the probe at the midpoint of the line connecting the posterior superior iliac spine and the greater trochanter of the femur. The long axis of the probe is parallel to the line. Ultrasound can identify a continuous hyperechoic line, the hip bone line, and The superior gluteal artery can be seen pulsing deep within the gluteus medius. The probe is moved caudally and medially until the continuous hyperechoic line of the hip is broken, ie the parasacral parallel movement technique. The ultrasound beam then intersects the larger sciatic notch, and the probe is moved further distally and parallel to the ischial spine along the lateral border of the greater sciatic notch, proximal to the sciatic spine, where the pudendal and inferior gluteal arteries pass from the lower border of the piriformis muscle. From the pelvis, when the ultrasound beam intersects the ischial spine, a hyperechoic shadow appears again, which is the sacrospinous ligament and the sacrotuberous ligament. The pudendal, inferior gluteal, and sciatic nerves, and the internal pudendal and inferior gluteal arteries are usually close together around the tip of the sciatic spine between the sacrospinous and sacrotuberous ligaments. When the probe is moved parallel to the caudal portion of the ischial spine, the smaller sciatic notch is reached, which is smooth and rounded and around which the internal obturator tendon wraps. Moving the probe parallel to the lesser sciatic notch more distally, at the acute angle between the coccyx and the obturator internus, the pudendal nerve, artery, and vein can be seen in the proximal portion of the pudendal canal. Using the in-plane needle entry technique, a sterile disposable needle is inserted into the plane from the medial end of the probe and advanced until the tip of the needle is near the pudendal nerve. Inserting the needle medially avoids contact of the needle with the ischial tuberosity and minimizes the risk of rectal perforation. When the puncture needle passed through the sacrotuberous ligament, there was an obvious sense of failure. When the needle was close to the pudendal nerve, no blood was withdrawn, and a total of 10 ml of 0.3% ropivacaine was slowly injected and withdrawn intermittently. , between the sacrotuberous ligament and the internal pudendal artery in a fusiform spread, adjust the needle tip position according to the spread. The body surface acupuncture method was used to measure the block level. When the sensory block took effect, the perineum and anus began to be numb, and no pain was felt by acupuncture. The patient was then instructed to perform levator ani motion, and the anus did not contract, indicating that the block was complete. After blocking one side, change position to block the other side. After it is clear that the block is complete, anesthesia induction is performed, followed by slow intravenous injection of etomidate 0.2-0.4 mg/kg, cis-atracurium 0.2 mg/kg, fentanyl 4 μg/kg, and mask pressure to give oxygen and denitrogenation 4.5 mg/kg. Endotracheal intubation was performed after min. The ventilation parameters were set as tidal volume 8ml/kg, respiratory rate 10-12 times/min, inspiratory ratio 1:2, and end-tidal carbon dioxide partial pressure (PETCO2) maintained at 35-45mmHg ( 1mmHg=0.133kPa), oxygen flow 2L/min. Anesthesia maintenance: inhalation of sevoflurane, maintaining the minimum effective alveolar concentration (MAC) at 1.0, infusion of dexmedetomidine hydrochloride 0.5ug·kg-1·h-1, remifentanil 0.1-0.2ug·kg-1 ·h-1, Propofol 4～6mg·kg-1·h-1, cisatracurium 0.05mg/kg intravenously every 40-50min to maintain muscle relaxation. During the operation, the BIS value was maintained at 40-60, and the infusion warmer was used for infusion, and the body temperature was maintained at 36-37°C with a thermal blanket. 

纳入标准：

Inclusion criteria

排除标准：

1.前列腺癌患者；
2.糖尿病患者；
3.严重尿路感染；
4.存在神经源性膀胱功能障碍；
5.近期曾使用Ｍ受体阻滞剂治疗的患者；
6.患有精神疾病或存在语言障碍的患者；
7.术前尿动力学提示逼尿肌无力者；
8.术前已安置膀胱造瘘管者；
9.有尿道狭窄、前列腺癌等非BPH引起的器质性膀胱出口梗阻者；
10.合并有下尿路结石者；
11.曾行前列腺或膀胱颈手术者；
12.已知对罗哌卡因或任何其他麻醉剂过敏者，穿刺部位有感染；
13.合并严重心血管疾病。

Exclusion criteria：

1. Patients with prostate cancer;
2. Patients with diabetes;
3. Severe urinary tract infection;
4. Neurogenic bladder dysfunction;
5. Patients who have recently been treated with M receptor blockers;
6. Patients with mental illness or language disorder;
7. Patients with detrusor weakness indicated by preoperative urodynamics;
8. The bladder fistula has been installed before the operation;
9. Those with urethral stricture, prostate cancer and other organic bladder outlet obstruction not caused by BPH;
10. Patients with lower urinary tract stones;
11. Those who have undergone prostate or bladder neck surgery;
12. The person known to be allergic to ropivacaine or any other anesthetic has infection at the puncture site;
13. Complicated with severe cardiovascular disease.

研究实施时间：

Study execute time：

从 From 2022-04-01 00:00:00至 To 2023-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-04-01 00:00:00 至 To 2023-04-01 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 60

Group：

Control group

Sample size：

干预措施：

只全身麻醉

干预措施代码：

Intervention：

General anesthesia only

Intervention code：

组别：

阴部神经阻滞组

样本量：

 60

Group：

Pudendal nerve block group

Sample size：

干预措施：

经阴部管水平阴部神经阻滞

干预措施代码：

Intervention：

Pudendal nerve block at the level of the pudendal canal

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 嘉兴市 

Country：

China

Province：

Zhejiang Province

City：

Jiaxing City

单位(医院)：

 嘉兴市第一医院 

单位级别：

 三级甲等 

Institution
hospital：

Jiaxing First Hospital

Level of the institution：

Third-class hospital

测量指标：

Outcomes：

指标中文名：

导尿管相关膀胱不适和膀胱痉挛发生率

指标类型：

主要指标

Outcome：

Incidence of catheter-related bladder discomfort and bladder spasm

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛视觉模拟评分

指标类型：

次要指标

Outcome：

pain visual analogue scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

4分法评估72h内CRBD严重程度

指标类型：

次要指标

Outcome：

4-point scale to assess the severity of CRBD within 72 hours

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后补救性镇痛药物用量

指标类型：

次要指标

Outcome：

Postoperative rescue analgesia dosage

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

0

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 50 岁 years
最大 Max age 90 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

由不参与麻醉过程，不参与数据整理及论文写作的实验者利用excel生成随机序列。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random sequences were generated using excel by experimenters who were not involved in the anesthesia process, data processing and paper writing.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

暂不公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not public yet

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

暂未开始

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Not yet started

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2022-04-07 23:09:27
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