A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
NCT ID: NCT05376904
Last Updated: 2023-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2022-06-13
2022-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HR18034 dose 1
HR18034
HR18034 low dose
HR18034 dose 2
HR18034
HR18034 midium dose
HR18034 dose 3
HR18034
HR18034 high dose
ropivacaine HCl
ropivacaine HCl.
ropivacaine HCl.
Interventions
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HR18034
HR18034 low dose
HR18034
HR18034 midium dose
HR18034
HR18034 high dose
ropivacaine HCl.
ropivacaine HCl.
Eligibility Criteria
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Inclusion Criteria
2. Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
3. 18 kg/m2 ≤ BMI ≤ 28 kg/m2
4. Conform to the ASA Physical Status Classification
5. Women of childbearing age have a negative pregnancy test and are not nursing
Exclusion Criteria
2. Subjects with atrioventricular block or cardiac insufficiency
3. Subjects with a history of ischemic stroke or transient ischemic attack
4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
5. Subjects with concurrent painful physical condition that may affect postoperative pain assessment
6. Subjects with myelopathy or spinal disease
7. Subjects with a history of hemorrhoidectomy
8. Abnormal values in the laboratory
9. Subject with a history of substance abuse and drug abuse
10. Subject with refractory hypertension
11. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study
12. History of substance abuse, drug use and/or alcohol abuse
13. HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening period;
14. Participated in clinical trials of other drugs (received experimental drugs)
15. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
18 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 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
Traditional Chinese Medicine Hospital of Hebei Province
Shijiazhuang, Hebei, China
Shiyan Taihe Hospital
Shiyan, Hubei, China
the first People's Hospital of Changde
Changde, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, 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
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
the First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
Li Huili Hospital of Ningbo Medical Center
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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HR18034-202
Identifier Type: -
Identifier Source: org_study_id
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