A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
- Conditions
- Postsurgical Pain Management
- Interventions
- Registration Number
- NCT05376904
- Lead Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Brief Summary
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Able and willing to provide a written informed consent
- Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
- 18 kg/m2 ≤ BMI ≤ 28 kg/m2
- Conform to the ASA Physical Status Classification
- Women of childbearing age have a negative pregnancy test and are not nursing
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with concurrent painful physical condition that may affect postoperative pain assessment
- Subjects with myelopathy or spinal disease
- Subjects with a history of hemorrhoidectomy
- Abnormal values in the laboratory
- Subject with a history of substance abuse and drug abuse
- Subject with refractory hypertension
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study
- History of substance abuse, drug use and/or alcohol abuse
- HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening period;
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ropivacaine HCl ropivacaine HCl. - HR18034 dose 2 HR18034 - HR18034 dose 1 HR18034 - HR18034 dose 3 HR18034 -
- Primary Outcome Measures
Name Time Method AUC of Pain Intensity in rest state 0~72 hours after administration Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 72 hours.
- Secondary Outcome Measures
Name Time Method Investigator's satisfaction score for analgesia treatment 72-hours AUC of Pain Intensity in rest state 0~24 hours，0~48 hours after administration AUC of Pain Intensity in rest state
Pain intensity in move state assessed using an 11-point NPRS ranging 0~72 hours after administration 11-point NPRS ranging from a score of 0 to 10
Participant's satisfaction score for analgesia treatment 72-hours AUC of Pain Intensity in move state 0~24 hours，0~48 hours，0~72 hours after administration AUC of Pain Intensity in move state
Pain intensity in rest state assessed using an 11-point NPRS ranging 0~72 hours after administration 11-point NPRS ranging from a score of 0 to 10
Proportion of subjects who doesn't recive rescue analgesic 0~72 hours after administration
Trial Locations
- Locations (18)
Li Huili Hospital of Ningbo Medical Center
🇨🇳Ningbo, Zhejiang, China
Central Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Dongguan people's Hospital
🇨🇳Dongguan, Guangdong, China
Nanning Second People's Hospital
🇨🇳Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Shiyan Taihe Hospital
🇨🇳Shiyan, Hubei, China
the first People's Hospital of Changde
🇨🇳Changde, Hunan, China
Taizhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
General Hospital of Northern Theater Command
🇨🇳Shenyang, Liaoning, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Jiaxing Second Hospital
🇨🇳Jiaxing, Zhejiang, China
Traditional Chinese Medicine Hospital of Hebei Province
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shanxi, China
Beijing Tongren Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
the First Affiliated Hospital of Xi'An Jiaotong University
🇨🇳Xi'An, Shanxi, China