Clinical trial NCT05376904: A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postsurgical Pain Management
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HR18034 compared with active comparator
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
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:

1. Subjects with a history of myocardial infarction or unstable angina pectoris
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

Primary outcomes:
measure: AUC of Pain Intensity in rest state
timeFrame: 0~72 hours after administration
Secondary outcomes:
measure: AUC of Pain Intensity in rest state
timeFrame: 0~24 hours，0~48 hours after administration
measure: AUC of Pain Intensity in move state
timeFrame: 0~24 hours，0~48 hours，0~72 hours after administration
measure: Pain intensity in rest state assessed using an 11-point NPRS ranging
timeFrame: 0~72 hours after administration
measure: Pain intensity in move state assessed using an 11-point NPRS ranging
timeFrame: 0~72 hours after administration
measure: Proportion of subjects who doesn't recive rescue analgesic
timeFrame: 0~72 hours after administration
measure: Participant's satisfaction score for analgesia treatment
timeFrame: 72-hours
measure: Investigator's satisfaction score for analgesia treatment
timeFrame: 72-hours
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated to Capital Medical University
state: Beijing
city: Dongguan
country: China
facility: Dongguan people's Hospital
state: Guangdong
city: Nanning
country: China
facility: Nanning Second People's Hospital
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: Traditional Chinese Medicine Hospital of Hebei Province
state: Hebei
city: Shiyan
country: China
facility: Shiyan Taihe Hospital
state: Hubei
city: Changde
country: China
facility: the first People's Hospital of Changde
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Taizhou
country: China
facility: Taizhou People's Hospital
state: Jiangsu
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Jinan
country: China
facility: Central Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Xi'An
country: China
facility: the First Affiliated Hospital of Xi'An Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Jiaxing
country: China
facility: Jiaxing Second Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Li Huili Hospital of Ningbo Medical Center
state: Zhejiang
Study officials:
References: