Status:
COMPLETED
A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Postsurgical Pain Management
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 postop...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05376904
Start Date
June 13 2022
End Date
October 5 2022
Last Update
March 20 2023
Active Locations (18)
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1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
2
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100005
3
Dongguan people's Hospital
Dongguan, Guangdong, China, 523000
4
Nanning Second People's Hospital
Nanning, Guangxi, China, 530000