ChiCTR2500097618 版本V1.0 版本创建时间2025/02/21 17:04:53 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：

ChiCTR2500097618 

最近更新日期：

Date of Last Refreshed on：

2025-02-21 17:04:42 

注册时间：

Date of Registration：

2025-02-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

延长静脉注射利多卡因时间治疗腹腔镜下子宫切除术患者术后疼痛的疗效：一项双盲、随机、安慰剂对照试验

Public title：

Efficacy of prolonged intravenous lidocaine for postoperative pain in patients undergoing laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

延长静脉注射利多卡因时间治疗腹腔镜下子宫切除术患者术后疼痛的疗效：一项双盲、随机、安慰剂对照试验

Scientific title：

Efficacy of prolonged intravenous lidocaine for postoperative pain in patients undergoing laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial

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：

苏小群 

研究负责人：

谢海辉 

Applicant：

Xiaoqun Su 

Study leader：

Haihui Xie 

申请注册联系人电话：

Applicant telephone：

+86 134 3521 8350

研究负责人电话：

Study leader's telephone：

+86 137 9058 8393

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：

1072963575@qq.com

研究负责人电子邮件：

Study leader's E-mail：

xhh900@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：

东莞市人民医院红楼院区麻醉手术中心

研究负责人通讯地址：

东莞市人民医院红楼院区麻醉手术中心

Applicant address：

Anesthesia Surgery Center, Honglou Hospital, Dongguan City

Study leader's address：

Anesthesia Surgery Center, Honglou Hospital, Dongguan City

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：

东莞市人民医院

Applicant's institution：

Dongguan People's Hospital

研究负责人所在单位：

东莞市人民医院

Affiliation of the Leader：

Dongguan People's Hospital

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：

KYKT2024-080-A1

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：

东莞市人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Dongguan People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-02-08 00:00:00

伦理委员会联系人：

袁领勤

Contact Name of the ethic committee：

Lingqin Yuan

伦理委员会联系地址：

东莞市万江街道万道路78号，东莞市人民医院硼中子治疗中心一楼 医学伦理委员会办公室

Contact Address of the ethic committee：

Office of Medical Ethics Committee,1st Floor, Boron Neutron Treatment Center, Dongguan People's Hospital,78 Wan Road, Wanjiang Street, Dongguan City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 769 2863 6365

伦理委员会联系人邮箱：

Contact email of the ethic committee：

dgrmyyirb@163.com

研究实施负责（组长）单位：

东莞市人民医院

Primary sponsor：

Dongguan People's Hospital

研究实施负责（组长）单位地址：

东莞市人民医院红楼院区麻醉手术中心

Primary sponsor's address：

Anesthesia Surgery Center, Honglou Hospital, Dongguan City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

东莞

Country：

China

Province：

Guangdong

City：

Dongguan

单位(医院)：

东莞市人民医院

具体地址：

东莞市万江街道万道路78号，东莞市人民医院

Institution
hospital：

Dongguan People's Hospital

Address：

Dongguan People's Hospital,78 Wan Road, Wanjiang Street, Dongguan City

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

patients undergoing laparoscopic hysterectomy:

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：

主要目的：评估围术期持续静脉输注利多卡因至术后24小时对腹腔镜下行子宫切除术患者术后疼痛的疗效和安全性。 次要目的：探讨延长利多卡因静脉输注时间对腹腔镜下行子宫切除术患者术后恢复、并发症发生率及患者满意度的影响。  

Objectives of Study：

Primary Objective: To evaluate the efficacy and safety of continuous perioperative intravenous infusion of lidocaine up to 24 hours postoperatively for postoperative pain in patients undergoing laparoscopic hysterectomy. Secondary Objective: To investigate the impact of extending the duration of intravenous lidocaine infusion on postoperative recovery, complication rates, and patient satisfaction in patients undergoing laparoscopic hysterectomy.

药物成份或治疗方案详述：

治疗期：麻醉诱导开始至手术结束后第24h。 （一）麻醉方案：全身麻醉，围术期全程需采用心电监护。 所有患者在研究前均不用药，入手术室后安静仰卧5min，开放外周静脉通路并输注复方氯化钠注射液，常规监测心率(HR)、血氧饱和度（SpO2)、心电图(ECG)和脑电双频指数（BIS），由研究者视患者及手术情况行有创动脉穿刺置管并监测血压(MAP)或者行深静脉穿刺置管。诱导前均予以去氮给氧3min（氧流量4L/min）。 术中全身麻醉用药规定如下： ①诱导期：丙泊酚2mg/kg，舒芬太尼 0.4μg/kg，顺式阿曲库铵0.2mg/kg，其他辅助药物（包括但不限于血管活性药物、昂丹司琼等）可常规给药，吸入纯氧。 ②维持期：瑞芬太尼0.05-2μg/kg/min,根据术中生命体征进行调整，记录瑞芬太尼用量。丙泊酚、顺式阿曲库铵由研究者决定用量及停药时间。血管活性药物、吸入麻醉药（如七氟醚）根据手术需求判断是否使用，常规监测脑电双频谱指数BIS，将BIS维持在40-60之间，吸入40%空气+60%氧气的混合气体，缝合手术切口时给予0.25%罗哌卡因20ml进行切口局部浸润麻醉防止术后爆发痛。 （二）麻醉诱导及麻醉维持期试验药品的使用： 1）试验药品的配置： ①麻醉诱导期：根据患者的理想体重按照1.5mg/kg配置1%利多卡因溶液到20ml的注射器，或者抽取等量的0.9%生理盐水； ②麻醉维持期：根据患者的理想体重按照1.5mg/kg/h配置1%利多卡因溶液到50ml注射器或等量0.9%生理盐水。 ③理想体重的计算公式： a.男性的理想体重=身高（cm）-100 b.女性的理想体重=身高（cm）-105 2）给药方案： A组：利多卡因组 a.麻醉诱导时给予1.5 mg/kg的利多卡因静脉推注（根据理想体重计算，给药时间＞10min）。 b.手术过程中持续输注1.5 mg/kg/h的利多卡因，直至手术结束（将外科医生缝皮结束的时间点视为手术结束）。 B组：安慰剂组 麻醉诱导时、术中维持使用等量的生理盐水。 （三）麻醉恢复期及术后24h内试验药品的使用： ①PCIA泵的成分组成： a.A组（利多卡因组）：术后24小时内使用包含利多卡因（15 mg/kg）、舒芬太尼（1 ug/kg）和托烷司琼（10 mg）、0.9%生理盐水稀释至100 ml的PCIA泵进行输注。 b.B组（安慰剂组）：术后24小时内使用包含舒芬太尼（1 ug/kg）和托烷司琼（10 mg）、0.9%生理盐水稀释至100 ml的PCIA泵进行输注。 ②PCIA参数设置：持续输注24h，背景输注速率为2ml/h，患者疼痛时按压镇痛泵，每次按压的推注体积为2ml，锁定间隔为15min。 ③手术结束后，转入麻醉恢复室后拔除气管导管，出麻醉恢复室前使用NRS评分评估疼痛程度，NRS评分＞3的患者，根据需要每3h以静脉注射5mg吗啡。 

Description for medicine or protocol of treatment in detail：

Treatment Period: From the initiation of anesthesia induction to 24 hours after the completion of surgery. (I) Anesthesia Protocol: General anesthesia will be administered, with continuous perioperative electrocardiographic monitoring. All patients will refrain from medication prior to the study. Upon entering the operating room, patients will lie quietly in a supine position for 5 minutes. A peripheral intravenous line will be established, and compound sodium chloride injection will be administered. Routine monitoring of heart rate (HR), oxygen saturation (SpO2), electrocardiogram (ECG), and bispectral index (BIS) will be performed. The investigator may perform invasive arterial catheterization for blood pressure monitoring (MAP) or central venous catheterization based on the patient's condition and surgical requirements. Pre-induction denitrogenation will be performed with 100% oxygen at a flow rate of 4 L/min for 3 minutes. Intraoperative Anesthetic Medications: 1. Induction Phase: - Propofol: 2 mg/kg - Sufentanil: 0.4 μg/kg - Cisatracurium: 0.2 mg/kg - Other adjunct medications (including but not limited to vasoactive drugs, ondansetron, etc.) may be administered as needed. - Pure oxygen will be inhaled. 2. Maintenance Phase: - Remifentanil: 0.05–2 μg/kg/min, adjusted based on intraoperative vital signs. The total dosage of remifentanil will be recorded. - Propofol and cisatracurium dosages and discontinuation times will be determined by the investigator. - Vasoactive drugs and inhaled anesthetics (e.g., sevoflurane) may be used as needed based on surgical requirements. - BIS will be routinely monitored and maintained between 40–60. - A gas mixture of 40% air and 60% oxygen will be inhaled. - At the time of surgical wound closure, 20 ml of 0.25% ropivacaine will be administered for local infiltration anesthesia to prevent postoperative breakthrough pain. (II) Use of Investigational Drugs During Anesthesia Induction and Maintenance: 1. Preparation of Investigational Drugs: - Induction Phase: - For the lidocaine group: Prepare a 1% lidocaine solution at 1.5 mg/kg based on the patient’s ideal body weight in a 20 ml syringe. - For the placebo group: Prepare an equivalent volume of 0.9% saline. - Maintenance Phase: - For the lidocaine group: Prepare a 1% lidocaine solution at 1.5 mg/kg/h based on the patient’s ideal body weight in a 50 ml syringe. - For the placebo group: Prepare an equivalent volume of 0.9% saline. - Ideal Body Weight Calculation: - Male: Ideal body weight = Height (cm) – 100 - Female: Ideal body weight = Height (cm) – 105 2. Administration Protocol: - Group A (Lidocaine Group): - Administer 1.5 mg/kg lidocaine intravenously during anesthesia induction (calculated based on ideal body weight, administered over >10 minutes). - Continuously infuse 1.5 mg/kg/h lidocaine during surgery until the end of surgery (defined as the time when the surgeon completes skin closure). - Group B (Placebo Group): - Administer an equivalent volume of saline during anesthesia induction and maintenance. (III) Use of Investigational Drugs During Anesthesia Recovery and the First 24 Hours Postoperatively: 1. Composition of PCIA Pump: - Group A (Lidocaine Group): - The PCIA pump will contain lidocaine (15 mg/kg), sufentanil (1 μg/kg), and tropisetron (10 mg), diluted with 0.9% saline to a total volume of 100 ml. -Group B (Placebo Group): - The PCIA pump will contain sufentanil (1 μg/kg) and tropisetron (10 mg), diluted with 0.9% saline to a total volume of 100 ml. 2. PCIA Pump Settings: - Continuous infusion for 24 hours with a background infusion rate of 2 ml/h. - Patients may self-administer bolus doses of 2 ml with a lockout interval of 15 minutes as needed for pain relief. 3.Postoperative Management: - After surgery, patients will be transferred to the post-anesthesia care unit (PACU) and extubated. - Before discharge from the PACU, pain intensity will be assessed using the Numeric Rating Scale (NRS). - Patients with an NRS score >3 may receive intravenous morphine 5 mg every 3 hours as needed. 

纳入标准：

1)年龄：18-65岁； 2)美国麻醉医师协会（ASA）分级1-3级； 3)择期行腹腔镜下子宫切除术的全麻患者； 4)受试者对本次试验的目的和意义有充分了解，自愿参加本次临床试验，并签署知情同意书。

Inclusion criteria

1)Age: 18-65 years old; 2)American Society of Anesthesiologists (ASA) physical status classification I-III; 3)Patients scheduled to undergo elective laparoscopic hysterectomy under general anesthesia; 4)Participants fully understand the purpose and significance of this trial, voluntarily agree to participate in this clinical trial, and sign an informed consent form.

排除标准：

1)体重小于40kg或大于100kg； 2)心律失常或收缩性心力衰竭：二、三度房室传导阻滞、EF＜50%； 3)严重肝功能障碍：AST、ALT、胆红素大于正常上限的2.5倍； 4)严重肾功能障碍：肌酐清除率小于60ml/min； 5)有其他器官转移性病变； 6)对任何一种试验药物过敏； 7)长期使用阿片类药物； 8)无法理解疼痛数字评分量表（NRS）； 9)既往有哮喘病史或术前检查提示有哮喘可能性的患者。

Exclusion criteria：

1) Body weight less than 40 kg or greater than 100 kg; 2) Arrhythmia or systolic heart failure: second- or third-degree atrioventricular block, EF < 50%; 3) Severe liver dysfunction: AST, ALT, or bilirubin levels exceeding 2.5 times the upper limit of normal; 4) Severe renal dysfunction: creatinine clearance rate less than 60 ml/min; 5) Presence of metastatic disease in other organs; 6) Allergy to any of the trial medications; 7) Long-term use of opioid medications; 8) Inability to understand the Numeric Rating Scale (NRS) for pain assessment; 9) History of asthma or preoperative findings suggesting the possibility of asthma;

研究实施时间：

Study execute time：

从 From 2025-02-20 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-02-21 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

利多卡因组

样本量：

107

Group：

Lidocaine Group

Sample size：

干预措施：

1、治疗期：麻醉诱导开始至手术结束后第24小时。 （1）麻醉方案： ①全身麻醉：围术期全程采用心电监护。 ②术前准备所有患者在研究前均不用药，入手术室后安静仰卧5分钟，开放外周静脉通路并输注复方氯化钠注射液，常规监测心率(HR)、血氧饱和度(SpO2)、心电图(ECG)和脑电双频指数(BIS)。根据患者及手术情况，行有创动脉穿刺置管并监测血压(MAP)或行深静脉穿刺置管。诱导前均予以去氮给氧3分钟（氧流量4L/min）。 （2）麻醉诱导期： ①药物：丙泊酚2mg/kg，舒芬太尼0.4μg/kg，顺式阿曲库铵0.2mg/kg，其他辅助药物（包括但不限于血管活性药物、昂丹司琼等）可常规给药，吸入纯氧。 ②试验药品：根据患者的理想体重按照1.5mg/kg配置1%利多卡因溶液到20ml的注射器，静脉推注（给药时间＞10分钟）。 （3）麻醉维持期： ①药物：瑞芬太尼0.05-2μg/kg/min，根据术中生命体征进行调整，记录瑞芬太尼用量。丙泊酚、顺式阿曲库铵由研究者决定用量及停药时间。血管活性药物、吸入麻醉药（如七氟醚）根据手术需求判断是否使用，常规监测脑电双频谱指数BIS，将BIS维持在40-60之间，吸入40%空气+60%氧气的混合气体。缝合手术切口时给予0.25%罗哌卡因20ml进行切口局部浸润麻醉防止术后爆发痛。 ②试验药品：根据患者的理想体重按照1.5mg/kg/h配置1%利多卡因溶液到50ml注射器，持续输注直至手术结束（将外科医生缝皮结束的时间点视为手术结束）。 （4）麻醉恢复期及术后24小时内： ①PCIA泵：术后24小时内使用包含利多卡因（15 mg/kg）、舒芬太尼（1 ug/kg）和托烷司琼（10 mg）、0.9%生理盐水稀释至100 ml的PCIA泵进行输注。 ②PCIA参数设置：持续输注24小时，背景输注速率为2ml/h，患者疼痛时按压镇痛泵，每次按压的推注体积为2ml，锁定间隔为15分钟。 ③术后疼痛管理：手术结束后，转入麻醉恢复室后拔除气管导管，出麻醉恢复室前使用NRS评分评估疼痛程度，NRS评分＞3的患者，根据需要每3小时以静脉注射5mg吗啡。

干预措施代码：

Intervention：

Intervention Measures for the Lidocaine Group **1. Treatment Period**: From the initiation of anesthesia induction to 24 hours after the end of surgery. **(1) Anesthesia Protocol**: ① **General Anesthesia**: Continuous ECG monitoring throughout the perioperative period. ② **Preoperative Preparation**: No medication is administered to any patient prior to the study. Upon entering the operating room, patients lie quietly in a supine position for 5 minutes. A peripheral intravenous access is established, and compound sodium chloride injection is infused. Routine monitoring of heart rate (HR), oxygen saturation (SpO2), electrocardiogram (ECG), and bispectral index (BIS) is performed. Depending on the patient's condition and surgical requirements, invasive arterial catheterization for blood pressure (MAP) monitoring or deep venous catheterization may be performed. Pre-induction, all patients receive 3 minutes of denitrogenation with oxygen (oxygen flow rate: 4 L/min). **(2) Anesthesia Induction Phase**: ① **Medications**: Propofol 2 mg/kg, sufentanil 0.4 μg/kg, cisatracurium 0.2 mg/kg. Other adjunct medications (including but not limited to vasoactive drugs, ondansetron, etc.) may be administered as per routine. Pure oxygen is inhaled. ② **Investigational Drug**: Based on the patient's ideal body weight, a 1% lidocaine solution is prepared at 1.5 mg/kg in a 20 ml syringe and administered intravenously (administration time > 10 minutes). **(3) Anesthesia Maintenance Phase**: ① **Medications**: Remifentanil 0.05-2 μg/kg/min, adjusted according to intraoperative vital signs, with remifentanil dosage recorded. The dosage and discontinuation time of propofol and cisatracurium are determined by the investigator. Vasoactive drugs and inhaled anesthetics (e.g., sevoflurane) are used as needed based on surgical requirements. Routine monitoring of the bispectral index (BIS) is maintained, keeping BIS between 40-60. A mixture of 40% air and 60% oxygen is inhaled. At the time of surgical wound closure, 20 ml of 0.25% ropivacaine is administered for local infiltration anesthesia to prevent postoperative breakthrough pain. ② **Investigational Drug**: Based on the patient's ideal body weight, a 1% lidocaine solution is prepared at 1.5 mg/kg/h in a 50 ml syringe and continuously infused until the end of surgery (defined as the time when the surgeon completes skin closure). **(4) Anesthesia Recovery Phase and Postoperative 24 Hours**: ① **PCIA Pump**: Within 24 hours postoperatively, a PCIA pump containing lidocaine (15 mg/kg), sufentanil (1 μg/kg), and tropisetron (10 mg), diluted to 100 ml with 0.9% saline, is used for infusion. ② **PCIA Parameter Settings**: Continuous infusion for 24 hours with a background infusion rate of 2 ml/h. Patients can press the analgesic pump for bolus doses when in pain, with each press delivering 2 ml and a lockout interval of 15 minutes. ③ **Postoperative Pain Management**: After surgery, patients are transferred to the recovery room, and the endotracheal tube is removed. Before discharge from the recovery room, pain intensity is assessed using the NRS score. Patients with an NRS score > 3 may receive intravenous morphine 5 mg every 3 hours as needed.

Intervention code：

组别：

安慰剂组

样本量：

107

Group：

Placebo Group

Sample size：

干预措施：

（1）治疗期：麻醉诱导开始至手术结束后第24小时。 （2）麻醉方案： ①全身麻醉：围术期全程采用心电监护。 ②术前准备：所有患者在研究前均不用药，入手术室后安静仰卧5分钟，开放外周静脉通路并输注复方氯化钠注射液，常规监测心率(HR)、血氧饱和度(SpO2)、心电图(ECG)和脑电双频指数(BIS)。根据患者及手术情况，行有创动脉穿刺置管并监测血压(MAP)或行深静脉穿刺置管。诱导前均予以去氮给氧3分钟（氧流量4L/min）。 （3）麻醉诱导期： ①药物：丙泊酚2mg/kg，舒芬太尼0.4μg/kg，顺式阿曲库铵0.2mg/kg，其他辅助药物（包括但不限于血管活性药物、昂丹司琼等）可常规给药，吸入纯氧。 ②试验药品：根据患者的理想体重抽取等量的0.9%生理盐水到20ml的注射器，静脉推注（给药时间＞10分钟）。 （4）麻醉维持期： ①药物：瑞芬太尼0.05-2μg/kg/min，根据术中生命体征进行调整，记录瑞芬太尼用量。丙泊酚、顺式阿曲库铵由研究者决定用量及停药时间。血管活性药物、吸入麻醉药（如七氟醚）根据手术需求判断是否使用，常规监测脑电双频谱指数BIS，将BIS维持在40-60之间，吸入40%空气+60%氧气的混合气体。缝合手术切口时给予0.25%罗哌卡因20ml进行切口局部浸润麻醉防止术后爆发痛。 ②试验药品：根据患者的理想体重抽取等量的0.9%生理盐水到50ml注射器，持续输注直至手术结束（将外科医生缝皮结束的时间点视为手术结束）。 （5）麻醉恢复期及术后24小时内： ①PCIA泵：术后24小时内使用包含舒芬太尼（1 ug/kg）和托烷司琼（10 mg）、0.9%生理盐水稀释至100 ml的PCIA泵进行输注。 ②PCIA参数设置：持续输注24小时，背景输注速率为2ml/h，患者疼痛时按压镇痛泵，每次按压的推注体积为2ml，锁定间隔为15分钟。 ③术后疼痛管理：手术结束后，转入麻醉恢复室后拔除气管导管，出麻醉恢复室前使用NRS评分评估疼痛程度，NRS评分＞3的患者，根据需要每3小时以静脉注射5mg吗啡。

干预措施代码：

Intervention：

Intervention Measures for the Placebo Group **(1) Treatment Period**: From the initiation of anesthesia induction to 24 hours after the end of surgery. **(2) Anesthesia Protocol**: ① **General Anesthesia**: Continuous ECG monitoring throughout the perioperative period. ② **Preoperative Preparation**: No medication is administered to any patient prior to the study. Upon entering the operating room, patients lie quietly in a supine position for 5 minutes. A peripheral intravenous access is established, and compound sodium chloride injection is infused. Routine monitoring of heart rate (HR), oxygen saturation (SpO2), electrocardiogram (ECG), and bispectral index (BIS) is performed. Depending on the patient's condition and surgical requirements, invasive arterial catheterization for blood pressure (MAP) monitoring or deep venous catheterization may be performed. Pre-induction, all patients receive 3 minutes of denitrogenation with oxygen (oxygen flow rate: 4 L/min). **(3) Anesthesia Induction Phase**: ① **Medications**: Propofol 2 mg/kg, sufentanil 0.4 μg/kg, cisatracurium 0.2 mg/kg. Other adjunct medications (including but not limited to vasoactive drugs, ondansetron, etc.) may be administered as per routine. Pure oxygen is inhaled. ② **Investigational Drug**: Based on the patient's ideal body weight, an equivalent volume of 0.9% saline is drawn into a 20 ml syringe and administered intravenously (administration time > 10 minutes). **(4) Anesthesia Maintenance Phase**: ① **Medications**: Remifentanil 0.05-2 μg/kg/min, adjusted according to intraoperative vital signs, with remifentanil dosage recorded. The dosage and discontinuation time of propofol and cisatracurium are determined by the investigator. Vasoactive drugs and inhaled anesthetics (e.g., sevoflurane) are used as needed based on surgical requirements. Routine monitoring of the bispectral index (BIS) is maintained, keeping BIS between 40-60. A mixture of 40% air and 60% oxygen is inhaled. At the time of surgical wound closure, 20 ml of 0.25% ropivacaine is administered for local infiltration anesthesia to prevent postoperative breakthrough pain. ② **Investigational Drug**: Based on the patient's ideal body weight, an equivalent volume of 0.9% saline is drawn into a 50 ml syringe and continuously infused until the end of surgery (defined as the time when the surgeon completes skin closure). **(5) Anesthesia Recovery Phase and Postoperative 24 Hours**: ① **PCIA Pump**: Within 24 hours postoperatively, a PCIA pump containing sufentanil (1 μg/kg) and tropisetron (10 mg), diluted to 100 ml with 0.9% saline, is used for infusion. ② **PCIA Parameter Settings**: Continuous infusion for 24 hours with a background infusion rate of 2 ml/h. Patients can press the analgesic pump for bolus doses when in pain, with each press delivering 2 ml and a lockout interval of 15 minutes. ③ **Postoperative Pain Management**: After surgery, patients are transferred to the recovery room, and the endotracheal tube is removed. Before discharge from the recovery room, pain intensity is assessed using the NRS score. Patients with an NRS score > 3 may receive intravenous morphine 5 mg every 3 hours as needed.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 东莞 

Country：

China 

Province：

Guangdong 

City：

Dongguan 

单位(医院)：

东莞市人民医院 

单位级别：

三甲 

Institution
hospital：

Dongguan People‘s Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后24h内中度至重度运动诱发痛的发生率

指标类型：

主要指标

Outcome：

The incidence of moderate to severe movement-evoked pain within 24 hours postoperatively.

Type：

Primary indicator

测量时间点：

术后第12h、术后第24h

测量方法：

数字评分量表

Measure time point of outcome：

At 12 hours postoperatively and at 24 hours postoperatively.

Measure method：

Numeric Rating Scale (NRS).

指标中文名：

术后48h内中度至重度运动诱发痛的发生率

指标类型：

次要指标

Outcome：

The incidence of moderate to severe movement-evoked pain within 48 hours postoperatively.

Type：

Secondary indicator

测量时间点：

术后第36h、术后第48h

测量方法：

数字评分量表

Measure time point of outcome：

At 36 hours postoperatively and at 48 hours postoperatively.

Measure method：

Numeric Rating Scale (NRS).

指标中文名：

术后24h内、48h内静息状态下中度至重度疼痛的发生率

指标类型：

次要指标

Outcome：

The incidence of moderate to severe pain at rest within 24 hours and 48 hours postoperatively.

Type：

Secondary indicator

测量时间点：

术后第12h、24h、36h、48h

测量方法：

数字评分量表

Measure time point of outcome：

At 12 hours, 24 hours, 36 hours, and 48 hours postoperatively.

Measure method：

Numeric Rating Scale (NRS).

指标中文名：

术后24h内、48h内累计阿片类药物使用量

指标类型：

次要指标

Outcome：

The cumulative opioid consumption within 24 hours and 48 hours postoperatively.

Type：

Secondary indicator

测量时间点：

术后24h、48h

测量方法：

在手术结束后48h内（包括第48h），如受试者按压镇痛泵后仍有镇痛需求且静息疼痛评分NRS＞3分，尽快进行补救镇痛治疗。补救药物选择吗啡注射液，单次静脉注射，每次剂量5mg。如受试者吗啡不耐受，根据研究中心常规选用其他阿片类镇痛药，记录术后24h、48h内累计补救阿片类药物消耗量；

Measure time point of outcome：

At 24 hours and 48 hours postoperatively.

Measure method：

Within 48 hours after the end of the surgery (including the 48th hour), if the subject still requires analgesia after pressing the analgesic pump and has a resting pain score of NRS > 3, rescue analgesic therapy should be administered as soon as possible. The rescue medication of choice is morphine injection, administered intravenously as a single dose of 5 mg each time. If the subject is intolerant to morphine, other opioid analgesics should be selected according to the routine practices of the

指标中文名：

胃肠功能恢复的时间(即患者术后首次排便或排气的时间)

指标类型：

次要指标

Outcome：

The time to recovery of gastrointestinal function (i.e., the time of the patient's first postoperative bowel movement or flatus).

Type：

Secondary indicator

测量时间点：

术后48h内

测量方法：

术前一天训练患者记录患者术后首次排便或排气的时间

Measure time point of outcome：

Within 48 hours postoperatively.

Measure method：

Train the patient one day before surgery to record the time of their first postoperative bowel movement or flatus.

指标中文名：

术后48h内PONV的发生率（包括术后48小时内发生的任何恶心、呕吐）

指标类型：

次要指标

Outcome：

The incidence of PONV within 48 hours postoperatively (including any nausea or vomiting occurring within the first 48 hours after surgery).

Type：

Secondary indicator

测量时间点：

术后48h内

测量方法：

通过术后访视询问患者是否存在任何程度的恶心、呕吐

Measure time point of outcome：

Within 48 hours postoperatively.

Measure method：

By conducting postoperative visits, inquire whether the patient has experienced any degree of nausea or vomiting.

指标中文名：

住院期间术后肺部并发症的发生率

指标类型：

次要指标

Outcome：

The incidence of postoperative pulmonary complications during the hospital stay.

Type：

Secondary indicator

测量时间点：

术后到患者出院期间

测量方法：

通过术后随访以及查阅患者住院病历病程记录追踪是否存在住院期间术后肺部并发症的发生，包括受试者在术后到出院前出现呼吸道感染、呼吸衰竭、胸腔积液、肺不张、气胸、支气管痉挛或吸入性肺炎等

Measure time point of outcome：

From the time of surgery until the patient's discharge.

Measure method：

Through postoperative follow-up and reviewing the patient's hospital medical records and progress notes, track the occurrence of postoperative pulmonary complications during the hospital stay, including respiratory infections, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonia that occur from the time of surgery until discharge.

指标中文名：

住院天数（定义为手术结束至出院的日子）

指标类型：

次要指标

Outcome：

Length of hospital stay (defined as the period from the end of surgery to discharge).

Type：

Secondary indicator

测量时间点：

术后患者出院时

测量方法：

通过查阅病历系统记录患者术后住院时长

Measure time point of outcome：

At the time of the patient's discharge postoperatively.

Measure method：

By reviewing the medical record system, document the patient's postoperative length of hospital stay.

指标中文名：

患者满意度评分

指标类型：

次要指标

Outcome：

Patient satisfaction score.

Type：

Secondary indicator

测量时间点：

术后第48h

测量方法：

术后第48h嘱受试者对疼痛控制和整体康复过程进行满意度评分，0表示“非常不满意”，10表示“非常满意”

Measure time point of outcome：

At 48 hours postoperatively.

Measure method：

At 48 hours postoperatively, instruct the patient to rate their satisfaction with pain control and the overall recovery process on a scale from 0 to 10, where 0 indicates "very dissatisfied" and 10 indicates "very satisfied."

指标中文名：

疼痛缓解程度评分

指标类型：

次要指标

Outcome：

Pain relief score

Type：

Secondary indicator

测量时间点：

术后第48h

测量方法：

术后第48h嘱患者对术后镇痛效果进行回忆，使用Likert量表对疼痛缓解程度进行评分，用 0-4 代表不同的缓解强度，0 为无缓解，1 轻度缓解，2 为中度缓解，3 为明显缓解，4 为完全缓解

Measure time point of outcome：

At 48 hours postoperatively.

Measure method：

At 48 hours postoperatively, ask the patient to recall the effectiveness of postoperative analgesia and rate the degree of pain relief using a Likert scale, where 0-4 represents different levels of relief intensity: 0 for no relief, 1 for mild relief, 2 for moderate relief, 3 for significant relief, and 4 for complete relief.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

由不参与研究的研究人员使用excel生成随机数列

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

Generating random number sequences in Excel by researchers not involved in the study.

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：

对受试者、麻醉医生、结局评估者、数据分析者设盲。

Blinding：

Blinding was implemented for the subjects, anesthesiologists, outcome assessors, and data analysts.

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）：

/

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

/

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：

本研究的数据采集和管理由两部分组成：病例记录表（Case Record Form, CRF）和电子数据采集与管理系统（Electronic Data Capture and Management System, EDC）。具体说明如下： 1. 病例记录表（CRF） （1）CRF是用于记录研究过程中所有受试者相关数据的纸质或电子表格，包括但不限于人口学信息、病史、手术相关信息、研究药物使用情况、术后疼痛评估、不良事件记录等。 （2）CRF由经过培训的研究人员在每次访视时填写，确保数据的准确性和完整性。 （3）所有CRF数据将由研究团队定期核对，确保与源文件（如医疗记录、实验室报告等）一致。 （4）填写完成的CRF将由数据管理人员进行二次核查，以确保数据的真实性和可靠性。 2. 电子数据采集与管理系统（EDC） （1）本研究将采用电子数据采集与管理系统（EDC）进行数据的录入、存储和管理。 （2）所有CRF中的数据将由经过授权的研究人员录入EDC系统。 （3）EDC系统将设置权限管理，确保只有授权人员可以访问和修改数据。 （4）数据管理人员将定期对EDC系统中的数据进行核查，确保数据的完整性和一致性。 （5）研究结束后，所有数据将被锁定并导出，用于统计分析。

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

The data collection and management for this study consist of two components: the Case Record Form (CRF) and the Electronic Data Capture and Management System (EDC). The specific details are as follows: 1.Case Record Form (CRF) (1) The CRF is a paper-based or electronic form used to record all relevant data of study participants during the research process, including but not limited to demographic information, medical history, surgical-related information, study drug usage, postoperative pain assessment, and adverse event records. (2) The CRF will be completed by trained research personnel during each visit to ensure the accuracy and completeness of the data. (3) All CRF data will be regularly cross-checked by the research team to ensure consistency with source documents (e.g., medical records, laboratory reports, etc.). (4) Completed CRFs will undergo secondary verification by data management personnel to ensure the authenticity and reliability of the data. 2. Electronic Data Capture and Management System (EDC) (1) This study will utilize an Electronic Data Capture and Management System (EDC) for data entry, storage, and management. (2) All data from the CRF will be entered into the EDC system by authorized research personnel. (3) The EDC system will implement access controls to ensure that only authorized personnel can access and modify the data. (4) Data management personnel will regularly review the data in the EDC system to ensure its completeness and consistency. (5) Upon study completion, all data will be locked and exported for statistical analysis.

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：

  2025-02-21 17:04:42