Clinical trial NCT05769855: A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo 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: PHASE3
Conditions: Postsurgical Pain Management
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 294
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 and placebo
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.


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 ≤ 30 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. Spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia
7. Subjects with a history of hemorrhoidectomy
8. Subjects with a history of constipation
9. Subjects with a history of perianal disease
10. Abnormal values in the laboratory
11. Subject with heart rate \<50 or \>100 beats per minute.
12. Subject with refractory hypertension
13. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study
14. History of prohibited drug use
15. Participants who may be affected by alcohol, or drug abstinence during the study period;
16. Participated in clinical trials of other drugs (received experimental drugs)
17. 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: Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change
timeFrame: 0~72 hours after administration
measure: Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation
timeFrame: 0~72 hours after administration
measure: AUC of Pain Intensity in rest state
timeFrame: 0~24 hours after administration
measure: AUC of Pain Intensity in move state
timeFrame: 0~24 hours，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: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: