ChiCTR2100054272 版本V1.2 版本创建时间2022/06/01 21:39:23 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2100054272 

最近更新日期：

Date of Last Refreshed on：

2022-06-01 21:34:34 

注册时间：

Date of Registration：

2021-12-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

盐酸罗哌卡因和酮咯酸氨丁三醇用于鼻内镜术后镇痛的应用研究

Public title：

Application study of ropivacaine hydrochloride and ketorolac tromethamine for postoperative analgesia after nasal endoscopy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

盐酸罗哌卡因和酮咯酸氨丁三醇用于鼻内镜术后镇痛的应用研究

Scientific title：

Application study of ropivacaine hydrochloride and ketorolac tromethamine for postoperative analgesia after nasal endoscopy

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：

郑丹丹 

研究负责人：

司马国旗 

Applicant：

Zheng Dandan 

Study leader：

Sima Guoqi 

申请注册联系人电话：

Applicant telephone：

+86 18339275923

研究负责人电话：

Study leader's telephone：

+86 13957308970

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：

1839275923@163.com

研究负责人电子邮件：

Study leader's E-mail：

smgq73@163.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 Road South, Nanhu District, Jiaxing, Zhejiang

Study leader's address：

1882 Zhonghuan Road South, Nanhu District, Jiaxing, Zhejiang

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

蚌埠医学院

Applicant's institution：

Bengbu Medical College

研究负责人所在单位：

Affiliation of the Leader：

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

LS2021-KY-361

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：

嘉兴市第一医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Jiaxing First Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2021-11-25 00:00:00

伦理委员会联系人：

钱建萍

Contact Name of the ethic committee：

Qian Jianping

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 Road South, Nanhu District, Jiaxing, Zhejiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

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 Road South, 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：

南湖区中环南路1882号

Institution
hospital：

Jiaxing First Hospital

Address：

1882 Zhonghuan Road South, Nanhu District

经费或物资来源：

自筹资金

Source(s) of funding：

self-financing

Target disease：

Postoperative analgesia after nasal endoscopy

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

鼻内镜手术自1990年自国外引进并推广后，一直是鼻腔手术的主要手段。与传统手术方法相比，它具有创伤小，手术痛苦减轻等优点。然而，由于鼻腔、鼻窦解剖位置比较特殊且形态不规则，术后鼻腔止血和塑形较为困难，因此长期以来术后一直使用鼻腔填塞物压迫鼻腔止血、防止术后术腔粘连等。填塞物常用不可吸收物有凡士林纱条、高膨胀海绵等；常用的可吸收物有纳吸棉、明胶海绵等。对于不可吸收物，常规填塞24-48h后取出，由于术后麻醉药物逐渐褪去，以及鼻腔填塞物的压迫，几乎所有患者都有鼻部胀痛、上唇疼痛、头痛，少数患者感面部麻木、口干、睡眠障碍等各种不适。多数患者认为其是围手术期最痛苦的经历。在拔出填塞物时对鼻腔造成的二次伤害，如出血、疼痛等更是让患者心里恐惧、疼痛加重。因此，选择合适术后镇痛方式，不仅能减轻患者术后疼痛，更有利于术后加速康复过程。 20世纪初，Crile9等提出“在疼痛发作之前进行镇痛”的超前镇痛，意为在术前、术中、术后通过减少伤害性刺激传入导致的外周和中枢敏化，以减轻术后急、慢性疼痛的发生。超前镇痛的主要方法有：局部浸润麻醉、神经阻滞、预先应用非甾体类抗炎药物、预先应用中枢抑制药物（如阿片类）、联合应用镇痛措施。目前认为联合镇痛是一种较为有效的镇痛方法，联合应用不同镇痛药物，既能得到最佳镇痛效果，又能减少麻醉药物的副作用。 酮咯酸氨丁三醇，即尼松（以下简称尼松），属于NSAIDs药物，被广泛用于临床术后镇痛。与阿片类药物相比，其镇痛作用可能有所延迟，但通常持续的时间较长。酮咯酸氨丁三醇与其他阿片类药物复合使用可减少其他药物用量，减少阿片类药物副作用。Ding等人的研究表明，尼松与芬太尼术后镇痛效果相当，且恶心、镇静等不良反应较少。目前尼松超前镇痛在分娩、骨折手术、烧伤科手术中均有应用。 盐酸罗哌卡因，是一种新型酰胺类局麻药。Gupta等在腹腔镜胆囊切除术后7d内，按需每次经埋置导管向胆囊床输注0．5％罗哌卡因 10ml用于术后镇痛 ，取得十分好的效果。Maestroni等在腹腔镜胆囊切除术气腹前腹腔注射5mg/kg的罗哌卡因溶液200ml，术后用视觉模拟法(VAS)评定疼痛程度及止痛效果，发现气腹前腹腔内使用罗哌卡因也可以达到明显的超前镇痛效果。另外，有研究表明，在静脉误注罗哌卡因 75mg～200mg的5个病例中，无一例呈现心脏毒性体症，提示盐酸罗哌卡因较其他局麻药物安全性高。 黄淑新等人发现，术后鼻腔内填塞盐酸罗哌卡因膨胀海绵可以缓解因填塞物引起的鼻部疼痛。Suheyl Haytoglu [等人通过对比鼻内镜术后术腔填塞不同类型的局麻药的镇痛效果，得出结论：除术后1h、24h外，0.25%布比卡因的镇痛效果优于其他对比组。盐酸罗哌卡因具有代谢快、半衰期长的特点，相较于同剂量和浓度的布比卡因来说，表现出低心血管毒性和低中枢神经毒性的药理作用，感觉阻滞和运动阻滞更加明显，且具有收缩血管的作用，故更适用于术后镇痛。目前有关尼松的超前镇痛与其他局麻药联合应用的相关研究不多，本研究通过观察鼻内镜术后盐酸罗哌卡因膨胀海绵的填塞与尼松超前镇痛联合填塞盐酸罗哌卡因膨胀海绵填塞的对比，旨在探究二者与安慰剂组对患者术后镇痛的效力进行探究。以便减轻鼻内镜术后患者疼痛，使患者顺利度过围手术期。  

Objectives of Study：

Since its introduction and promotion from abroad in 1990, nasal endoscopic surgery has been the main means of nasal surgery. Compared with traditional surgical methods, it has the advantages of less trauma and less surgical pain. However, due to the special anatomical location and irregular shape of the nasal cavity and sinuses, it is difficult to stop the bleeding and shape of the nasal cavity after surgery, therefore, nasal plugs have been used for a long time to compress the nasal cavity to stop bleeding and prevent postoperative cavity adhesions. Commonly used non-absorbable stuffing materials include Vaseline gauze, high expansion sponge, etc.; commonly used absorbable materials include nasal absorbent cotton, gelatin sponge, etc. Due to the gradual fading of postoperative anesthetic drugs and the pressure of nasal stuffing, almost all patients have nasal distension, upper lip pain, headache, and a few patients feel various discomforts such as facial numbness, dry mouth, and sleep disorders. Most patients consider it to be the most painful experience in the perioperative period. The secondary injury to the nasal cavity during the removal of the filling, such as bleeding and pain, adds to the fear and pain in the patient's heart. Therefore, choosing the appropriate postoperative analgesic modality not only reduces the postoperative pain of patients, but also helps to accelerate the postoperative recovery process. In the early 20th century, Crile9 and others proposed "analgesia before the onset of pain", which means to reduce the occurrence of acute and chronic postoperative pain by reducing the peripheral and central sensitization caused by the afferent of injurious stimuli before, during and after surgery. The main methods of hyper-analgesia are: local infiltration anesthesia, nerve block, pre-application of non-steroidal anti-inflammatory drugs, pre-application of central depressants (e.g. opioids), and co-application of analgesic measures. At present, it is considered that combined analgesia is a more effective analgesic method, and the combined application of different analgesic drugs can obtain the best analgesic effect and reduce the side effects of anesthetic drugs. Aminotriol ketorolac, or nisone (hereinafter referred to as nisone), belongs to NSAIDs drugs and is widely used for clinical postoperative analgesia. Its analgesic effect may be delayed compared to opioids, but usually lasts longer. The combination of aminotriol ketorolac and other opioids can reduce the dosage of other drugs and reduce opioid side effects. a study by Ding et al. showed that nisone was comparable to fentanyl for postoperative analgesia and had fewer adverse effects such as nausea and sedation. At present, nisone over-the-top analgesia is used in childbirth, fracture surgery, and burn unit surgery. Ropivacaine hydrochloride, a new type of amide local anesthetic, was used for postoperative analgesia by infusion of 0.5% ropivacaine 10 ml into the gallbladder bed via a buried catheter as needed for 7 d after laparoscopic cholecystectomy, with very good results. The visual analogue method (VAS) was used to assess the pain level and analgesic effect, and it was found that the use of ropivacaine intraperitoneally before pneumoperitoneum could also achieve a significant overt analgesic effect. In addition, a study showed that in five cases of intravenous misinjection of ropivacaine 75 mg to 200 mg, none of them presented cardiotoxic signs, suggesting that ropivacaine hydrochloride is safer than other local anesthetic drugs. Huang Shuxin et al. found that postoperative intra-nasal filling with ropivacaine hydrochloride expansion sponges could relieve nasal pain caused by the filling, and Suheyl Haytoglu [et al. concluded that the analgesic effect of 0.25% bupivacaine was superior to other comparison groups by comparing the analgesic effect of different types of local anesthetics for postoperative filling of the nasal cavity after endoscopy, except for 1h and 24h after surgery. Ropivacaine hydrochloride has the characteristics of fast metabolism and long half-life, and exhibits low cardiovascular toxicity and low central neurotoxicity pharmacologically compared to bupivacaine at the same dose and concentration, with more pronounced sensory blockade and motor blockade and vasoconstrictive effect, so it is more suitable for postoperative analgesia. There are not many studies related to the combination of over-the-counter analgesia of nisone with other local anesthetics, and this study aims to investigate the efficacy of both versus the placebo group for postoperative analgesia in patients by observing the comparison between the filling of ropivacaine hydrochloride expanded sponge and nisone over-the-counter analgesia combined with ropivacaine hydrochloride expanded sponge filling after nasal endoscopy. In order to reduce postoperative patient pain after nasal endoscopy and to enable patients to pass through the perioperative period successfully.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1、需行鼻内镜手术治疗的患者
2、术后需行双侧鼻腔填塞的患者
3、ASA分级：I-II级
4、BMI指数在19-28kg/m2

Inclusion criteria

1、Patients who need to be treated by nasal endoscopy
2、Patients who need to perform bilateral nasal cavity filling after surgery
3、ASA classification: Grade I-II
4、BMI in the range of 19-28kg/m2

排除标准：

1、变应性鼻炎、鼻腔肿瘤患者
2、排除肝肾功能不全、凝血功能障碍、高血压、糖尿病控制不佳等其他心脑血管疾病患者
有消化道溃疡病史者

Exclusion criteria：

1、Patients with allergic rhinitis and nasal tumors
2、Excluding patients with other cardiovascular diseases such as liver and kidney insufficiency, coagulation dysfunction, hypertension and poorly controlled diabetes
3、Patients with a history of peptic ulcer

研究实施时间：

Study execute time：

从 From 2021-12-01 00:00:00至 To 2022-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-12-12 00:00:00 至 To 2022-07-12 00:00:00  

干预措施：

Interventions：

组别：

A组

样本量：

30

Group：

Group A

Sample size：

干预措施：

术前应用酮咯酸氨丁三醇和术后应用盐酸罗哌卡因浸泡海绵填塞术腔

干预措施代码：

Intervention：

Pre-operative application of aminotriol ketorolac and post-operative application of ropivacaine hydrochloride soaked sponge to fill the operative cavity

Intervention code：

组别：

B组

样本量：

30

Group：

Group B

Sample size：

干预措施：

术后应用盐酸罗哌卡因浸泡海绵填塞术腔

干预措施代码：

Intervention：

Postoperative application of Ropivacaine Hydrochloride soaked sponge to fill the operative cavity

Intervention code：

组别：

C组

样本量：

30

Group：

Group C

Sample size：

干预措施：

术后应用生理盐水浸泡海绵填塞术腔

干预措施代码：

Intervention：

Postoperative application of saline-soaked sponges to fill the operative cavity

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

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 

单位级别：

三级甲等 

Institution
hospital：

Jiaxing First Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

NRS疼痛评分

指标类型：

主要指标

Outcome：

Numerical rating scale pain score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

首次额外追加补救镇痛药物的时间、例数

指标类型：

次要指标

Outcome：

Time and number of additional rescue analgesics for the first time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后不良反应发生率（恶心、呕吐、头痛）

指标类型：

次要指标

Outcome：

Incidence of postoperative adverse reactions (nausea, vomiting, headache)

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：

Null

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由与本次试验无直接关系的第三方人员将1-90号使用SAS软件随机生成90个随机数字，Seed设定为100。将生成的随机数字按大小排序，其中1-30号为A组(酮咯酸氨丁三醇和盐酸罗哌卡因组），31-60号为B组（盐酸罗哌卡因组），61-90号为C组（生理盐水组）。

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

Numbers 1-90 were randomly generated by third-party personnel not directly related to this trial using SAS software to generate 90 random numbers with Seed set to 100. the generated random numbers were sorted by size, with numbers 1-30 being group A (Ketorolac Tromethamine and Ropivacaine Hydrochloride), numbers

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

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）：

原始数据和研究计划书在试验完成后公开，公众可在临床研究公共管理平台Resman查询到原始数据。

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

Metadata and study protocols are made public upon completion of the trial and are available to the public on Resman, the public management platform for clinical research.

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：

均使用Resman管理

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

All managed using Resman

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：

  2021-12-12 10:06:44