ChiCTR2400089329 版本V1.0 版本创建时间2024/09/05 17:43:38 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：

 ChiCTR2400089329 

最近更新日期：

Date of Last Refreshed on：

 2024-09-05 17:43:33 

注册时间：

Date of Registration：

 2024-09-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

不同浓度罗哌卡因注射液在非头颈、非心脏手术患者中进行神经阻滞或者局部浸润术后镇痛的有效性和安全性探索：一项随机、双盲、安慰剂对照的临床研究

Public title：

Efficacy and safety of different concentrations of ropivacaine injection for postoperative analgesia after nerve block or local infiltration in non-head and neck and non-heart surgery patients: a randomized, double-blind, controlled study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

不同浓度罗哌卡因注射液在非头颈、非心脏手术患者中进行神经阻滞或者局部浸润术后镇痛的有效性和安全性探索：一项随机、双盲、安慰剂对照的临床研究

Scientific title：

Efficacy and safety of different concentrations of ropivacaine injection for postoperative analgesia after nerve block or local infiltration in non-head and neck and non-heart surgery patients: a randomized, double-blind, controlled study

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：

石国勳 

研究负责人：

汪赛赢 

Applicant：

Shi Guoxun 

Study leader：

Wang Saiying 

申请注册联系人电话：

Applicant telephone：

 +86 188 7616 5514

研究负责人电话：

Study leader's
telephone：

+86 158 7485 8486

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：

 shihkuoxun0528@163.com

研究负责人电子邮件：

Study leader's E-mail：

 1771303488@qq.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：

湖南省长沙市河西岳麓区桐梓坡路138号

研究负责人通讯地址：

湖南省长沙市河西岳麓区桐梓坡路138号

Applicant address：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hu'nan

Study leader's address：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hu'nan

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：

中南大学湘雅三医院

Applicant's institution：

Third Xiangya Hospital, Central South University

研究负责人所在单位：

中南大学湘雅三医院

Affiliation of the Leader：

Third Xiangya Hospital, Central South University

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：

 R23049

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

Ethics Committee of Xiangya Third Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-11-29 00:00:00

伦理委员会联系人：

何庆南

Contact Name of the ethic committee：

He Qingnan

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号

Contact Address of the ethic committee：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hu'nan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 8861 8938

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：

中南大学湘雅三医院麻醉科

Primary sponsor：

Anesthesiology department, Third Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

湖南省长沙市河西岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hu'nan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅三医院

具体地址：

湖南省长沙市河西岳麓区桐梓坡路138号

Institution
hospital：

Third Xiangya Hospital, Central South University

Address：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hu'nan

经费或物资来源：

自筹经费

Source(s) of funding：

Raise independently

研究疾病：

术后切口急性疼痛  

Target disease：

Acute postoperative incision pain

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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价不同浓度罗哌卡因注射液用于神经阻滞(神经干阻滞和神经末梢局部浸润阻滞)对非头颈、非心脏手术患者术后镇痛的的有效性和安全性。  

Objectives of Study：

To evaluate the efficacy and safety of different concentrations of ropivacaine injection in nerve block (nerve stem block and nerve end local infiltration block) for postoperative analgesia in non-head and neck, non-cardiac surgery patients.

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) 年龄 18 -75周岁(包括临界值)，性别不限； 2) 经临床诊断需择期全身麻醉下行腹腔镜下胆囊切除术的手术患者； 3) 体重：50 -90kg(包括临界值)；体重指数(BMI)19 kg/m2 ≤BMI≤30kg/m2，BMI=体重(kg)/身高2(m2)； 4) 符合美国麻醉医师学会(ASA)体格状态分级 Ⅰ–III 级风险评估标准； 5) 患者充分了解试验目的和要求，同意参加本试验并自愿签署知情同意书.

Inclusion criteria

1) Age 18-75 years old (including the critical value), gender is not limited; 2) Clinical diagnosis requires elective general anesthesia for non-head and neck, non-heart (such as laparoscopy; Hip replacement) surgery patients; 3) Weight: 50-90kg (including the critical value); Body mass index (BMI)19 kg/m2 ≤BMI≤30kg/m2, BMI= weight (kg)/ height 2(m2); 4) Meet the American College of Anesthesiologists (ASA) physical status Grade I - III risk assessment standards; 5) Patients fully understand the purpose and requirements of the experiment, agree to participate in the experiment and voluntarily sign the informed consent.

排除标准：

1) 对本研究试验药物、对照药物、手术麻醉药物、补救镇痛药物或药物中任何成分或同类药物过敏者，或属于过敏性体质或疤痕体质者； 2) 随机前存在对麻醉药品依赖或耐受的患者； 3) 不能理解NRS评分及不能配合使用静脉镇痛泵 PCIA 者； 4) 合并有严重心脑血管(如心力衰竭NYHA分级为III或IV级)、不稳定性心绞痛、急性心肌梗死、严重的心律失常、难治性高血压、脑梗塞、脑出血等，严重呼吸系统(如严重支气管哮喘、肺源性心脏病等)及神经和精神系统疾病患者； 5) 有对罗哌卡因、标准麻醉操作的禁忌症； 6) 合并疾病伴有明显疼痛，需在术后使用镇痛药治疗非手术相关的疼痛，可能干扰术后评价者； 7) 随机前两年内有酗酒史、药物滥用史者； 8) 筛选期使用了以下任何一种药物或治疗：1)随机前距离末次使用CYP1A2 强抑制剂(如阿扎那韦、依诺沙星、炔雌醇、氟伏沙明等)的时间短于该药物的5个半衰期；2)随机前距离末次使用阿片类或非阿片类(如对乙酰氨基酚，阿司匹、吲哚美辛、双氯芬酸、帕瑞昔布钠等非甾体类抗炎药）镇痛药的时间短于该药物的5个半衰期或药物疗效持续时间(以最长时间计算)；3)在筛选前3个月内，因任何原因连续使用阿片类镇痛药超过10天； 9) 肝功能衰竭患者； 10) 肾脏衰竭患者； 11) 高出血风险患者，包括先天性出血疾病患者(如血友病)、血小板减少患者(血小板计数低于 30×109/L)、血小板功能异常患者或有临床意义的任何活动性出血的患者； 12) 研究者认为具有任何其他可能影响试验结果、增加受试者风险等不宜参加此临床研究因素的受试者.

Exclusion criteria：

1) People who are allergic to the test drug, control drug, surgical anesthetic drug, remedial analgesic drug or any component of the drug or similar drugs, or who are allergic or scar constitution; 2) Patients who were dependent on or tolerant to narcotic drugs before randomization; 3) Unable to understand the NRS score and unable to use intravenous analgesia pump PCIA; 4) Patients with severe cardiovascular and cerebrovascular diseases (such as heart failure with NYHA grade III or IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, refractory hypertension, cerebral infarction, cerebral hemorrhage, etc., severe respiratory system (such as severe bronchial asthma, pulmonary heart disease, etc.) and neurological and psychiatric diseases; 5) There are contraindications to ropivacaine and standard anesthesia procedures; 6) Patients who are complicated with obvious pain and need to use analgesics to treat non-surgical related pain after surgery, which may interfere with postoperative evaluation; 7). Had a history of alcohol abuse or drug abuse within two years prior to randomization; 8) Any of the following drugs or treatments were used during the screening period: 1) the time from the last use of CYP1A2 potent agents (such as azanavir, enoxacin, ethoestradiol, fluvoxamine, etc.) before randomization was shorter than 5 half-lives of the drug; 2) The time between the last use of an opioid or non-opioid analgesic (e.g., acetaminophen, aspirin, indomethacin, diclofenac, parecoxib sodium, etc.) before randomization is shorter than the 5 half-life of the drug or the duration of the drug effect (calculated as the longest); 3) Continuous use of opioid analgesics for any reason for more than 10 days in the 3 months prior to screening; 9). Patients with liver failure; 10). Patients with kidney failure; 11). Patients at high blood risk, including those with congenital bleeding disorders (such as hemophilia), thrombocytopenia (platelet count below 30×109/L), abnormal platelet function, or any clinically significant active bleeding; 12) Subjects who have any other factors that the investigator deems inappropriate to participate in this clinical study that may affect the test results or increase the risk of the subjects.

研究实施时间：

Study execute time：

从 From 2024-04-25 00:00:00至 To 2025-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-25 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

神经干-0.5%罗哌卡因注射液浓度组

样本量：

 30

Group：

Nerve trunk -0.5% ropivacaine injection concentration group

Sample size：

干预措施：

全身麻醉实施前超声引导定位，然后在超声引导下向相应的神经干周围注射0.5%罗哌卡因注射液行神经阻滞

干预措施代码：

Intervention：

Before general anesthesia, ultrasound-guided localization was performed, and then 0.5% ropivacaine was injected around the corresponding nerve trunk for nerve block under ultrasound guidance

Intervention code：

组别：

神经干-0.375%罗哌卡因注射液浓度组

样本量：

 30

Group：

Nerve trunk -0.375% ropivacaine injection concentration group

Sample size：

干预措施：

全身麻醉实施前超声引导定位，然后在超声引导下向相应的神经干周围注射0.375%罗哌卡因注射液行神经阻滞

干预措施代码：

Intervention：

Before general anesthesia, ultrasound-guided localization was performed, and then 0.375% ropivacaine was injected around the corresponding nerve trunk for nerve block under ultrasound guidance

Intervention code：

组别：

神经干-0.25%罗哌卡因注射液浓度组

样本量：

 30

Group：

Nerve trunk -0.25% ropivacaine injection concentration group

Sample size：

干预措施：

全身麻醉实施前超声引导定位，然后在超声引导下向相应的神经干周围注射0.25%罗哌卡因注射液行神经阻滞

干预措施代码：

Intervention：

Before general anesthesia, ultrasound-guided localization was performed, and then 0.25% ropivacaine was injected around the corresponding nerve trunk for nerve block under ultrasound guidance

Intervention code：

组别：

神经干-0.9%氯化钠注射液浓度组

样本量：

 30

Group：

Nerve trunk -0.9% sodium chloride injection concentration group

Sample size：

干预措施：

全身麻醉实施前超声引导定位，然后在超声引导下向相应的神经干周围注射0.9%氯化钠注射液行神经阻滞

干预措施代码：

Intervention：

Before general anesthesia, ultrasound-guided positioning was performed, and then 0.9% sodium chloride injection was injected around the corresponding nerve trunk for nerve block under ultrasound guidance

Intervention code：

组别：

局麻-0.375%罗哌卡因注射液浓度组

样本量：

 30

Group：

Local anesthesia -0.375% ropivacaine injection concentration group

Sample size：

干预措施：

手术缝皮缝合完最后一针前，从切口边缘进针，切口周围单次多点皮下注射试验药物，每个注射点注射 2 mL注射液，注射点距离切口1 cm，环切口周围一圈按对应给药组要求的给药间隔给药。

干预措施代码：

Intervention：

Before the last stitch was closed, the needle was inserted from the edge of the incision, and a single subcutaneous injection of 2 mL of injection was injected around the incision at each injection point. The injection point was 1 cm away from the incision, and a circle around the incision was given according to the administration interval required by the corresponding administration group.

Intervention code：

组别：

局麻-0.25%罗哌卡因注射液浓度组

样本量：

 30

Group：

Local anesthesia -0.25% ropivacaine injection concentration group

Sample size：

干预措施：

手术缝皮缝合完最后一针前，从切口边缘进针，切口周围单次多点皮下注射试验药物，每个注射点注射 2 mL注射液，注射点距离切口1 cm，环切口周围一圈按对应给药组要求的给药间隔给药。

干预措施代码：

Intervention：

Before the last stitch was closed, the needle was inserted from the edge of the incision, and a single subcutaneous injection of 2 mL of injection was injected around the incision at each injection point. The injection point was 1 cm away from the incision, and a circle around the incision was given according to the administration interval required by the corresponding administration group.

Intervention code：

组别：

局麻-0.15%罗哌卡因注射液浓度组

样本量：

 30

Group：

Local anesthesia -0.15% ropivacaine injection concentration group

Sample size：

干预措施：

手术缝皮缝合完最后一针前，从切口边缘进针，切口周围单次多点皮下注射试验药物，每个注射点注射 2 mL注射液，注射点距离切口1 cm，环切口周围一圈按对应给药组要求的给药间隔给药。

干预措施代码：

Intervention：

Before the last stitch was closed, the needle was inserted from the edge of the incision, and a single subcutaneous injection of 2 mL of injection was injected around the incision at each injection point. The injection point was 1 cm away from the incision, and a circle around the incision was given according to the administration interval required by the corresponding administration group.

Intervention code：

组别：

局麻-0.9%氯化钠注射液浓度组

样本量：

 30

Group：

Local anesthesia -0.9% sodium chloride injection concentration group

Sample size：

干预措施：

手术缝皮缝合完最后一针前，从切口边缘进针，切口周围单次多点皮下注射试验药物，每个注射点注射 2 mL注射液，注射点距离切口1 cm，环切口周围一圈按对应给药组要求的给药间隔给药。

干预措施代码：

Intervention：

Before the last stitch was closed, the needle was inserted from the edge of the incision, and a single subcutaneous injection of 2 mL of injection was injected around the incision at each injection point. The injection point was 1 cm away from the incision, and a circle around the incision was given according to the administration interval required by the corresponding administration group.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三甲 

Institution
hospital：

Third Xiangya Hospital, Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

受试者接受试验药后0-72 h舒芬太尼的累积使用量

指标类型：

主要指标

Outcome：

The cumulative dosage of sufentanil was calculated from 0 h to 72 h after receiving the test drug

Type：

Primary indicator

测量时间点：

72小时

测量方法：

计算患者术后0-72小时镇痛泵内使用舒芬太尼使用总量

Measure time point of outcome：

72 h

Measure method：

The total amount of sufentanil used in the analgesia pump during 0-72 hours after surgery was calculated

指标中文名：

受试者苏醒后0-12 h、0-24 h、0-36 h、0-48 h、0-60 h、0-72 h的切口静息疼痛强度-时间曲线下面积(AUC)

指标类型：

次要指标

Outcome：

The area under the intensity time curve (AUC) of incision resting pain at 0-12 h, 0-24 h, 0-36 h, 0-48 h, 0-60 h, and 0-72 h after awakening of the subjects

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试者苏醒后0-12 h、0-24 h、0-36 h、0-48 h、0-60 h用于切口痛的补救镇痛药的累积使用量/公斤体重

指标类型：

次要指标

Outcome：

Cumulative dosage of rescue analgesics/kg body weight for incisional pain at 0-12 h, 0-24 h, 0-36 h, 0-48 h, and 0-60 h after awakening

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试者苏醒后0-12 h、0-24 h、0-36 h、0-48 h、0-60 h、0-72 h补救镇痛药的总累积使用量

指标类型：

次要指标

Outcome：

The total cumulative dosage of rescue analgesics during 0-12 h, 0-24 h, 0-36 h, 0-48 h, 0-60 h, and 0-72 h after awakening

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

首次因切口痛请求使用补救镇痛药的时间

指标类型：

次要指标

Outcome：

Time to first request for rescue analgesic for incisional pain

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试者苏醒后72 h内未因切口痛使用补救镇痛药物的受试者比例

指标类型：

次要指标

Outcome：

The proportion of subjects who did not use rescue analgesics for incisional pain within 72 h after emergence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试者疼痛满意度

指标类型：

次要指标

Outcome：

Subjects' pain satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试者术后胃肠道首次通气的时间

指标类型：

次要指标

Outcome：

The time of first postoperative gastrointestinal ventilation

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：

None

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

本试验将采用交互式网络应答系统（Interactive Web Randomization System, IWRS）实现受试者和药物的随机化。所有符合入选标准且不符合排除标准的受试者按照手术方式（腹腔镜手术和髋关节置换术）分层后，采用区组随机化方法，腹腔镜手术患者接受神经干阻滞，按照1:1:1:1比例，随机分配到试验组高浓度组-A、中浓度组-A、低浓度组-A以及安慰剂组-A；髋关节置换术患者接受神经末梢局部浸润阻滞的的受试者，按照1:1:1:1比例，随机分配到试验组高浓度组-B、中浓度组-B、低浓度组-B以及安慰剂组-B。

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

An Interactive Web Randomization System (IWRS) will be used to randomize subjects and drugs. All subjects who met the inclusion criteria and did not meet the exclusion criteria were stratified according to the surgical method (laparoscopic surgery and hip replacement), and block randomization method was used. Laparoscopic patients receiving nerve stem block were randomly assigned to the experimental group high-concentration group-A, medium-concentration group-A, low-concentration group-A, and placebo group-A according to the ratio of 1:1:1:1. Hip replacement patients receiving local infiltration block of nerve endings were randomly assigned to high-concentration group B, medium-concentration group B, low-concentration group B, and placebo group B at a ratio of 1:1:1:1.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本试验采用双盲设计，盲态研究团队和受试者均保持盲态。由于试验组与氯化钠注射液外包装不一致，为减少偏倚和人为干预因素，本试验专设盲态和非盲态研究团队。 非盲态研究团队人员负责试验药物的配制。除上述非盲态研究团队人员外，本试验的其他参与者不得试图了解受试者所在组别或接受的是哪一种试验用药品。 盲态研究团队人员负责本试验涉及相关指标评价、观察、记录等规定的盲态信息等工作。 盲态研究者需保持盲法，除非了解受试者的治疗分配是对临床管理或受试者获益是必要的。揭盲的原因将被清楚地记录下来。

Blinding：

The trial had a double-blind design, with both the blinded research team and the subjects remaining blinded. Due to the inconsistency between the experimental group and the sodium chloride injection packaging, in order to reduce bias and human intervention factors, this trial was designed to set up blinded and unblinded research teams. Unblinded study team members formulated the trial drugs. No trial participants other than those described above who were on the unblinded research team were allowed to attempt to learn the group in which a participant was assigned or which investigational product he or she received. The blinded research team members were responsible for the blinded information related to the evaluation of related indicators, observation, and recording. The blinded investigator remained blinded unless knowledge of the subject's treatment assignment was necessary for clinical management or for the benefit of the subject. The reason for unblinding will be clearly documented.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

共享方式：网络平台（http://www.medresman.org.cn/）；日期：2025年8月-12月

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

Research Manager http://www.medresman.org.cn/login.aspx; August 2025 to December 2025

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：

病历记录表

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

Case Record Form

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：

  2024-09-05 17:43:33