Postsurgical Pain Management
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
Interventions
DRUGHR18034
HR18034 380mg
DRUGropivacaine HCl
ropivacaine HCl 75mg.
DRUGSodium Chloride Physiological Solution
Sodium Chloride Physiological Solution 20ml
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HR18034 compared with active comparator and placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation | 0~72 hours after administration |
| AUC of Pain Intensity in rest state | 0~24 hours after administration |
| AUC of Pain Intensity in move state | 0~24 hours，0~72 hours after administration |
| Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change | 0~72 hours after administration |
| Participant's satisfaction score for analgesia treatment | 72-hours |
| Investigator's satisfaction score for analgesia treatment | 72-hours |
| Proportion of subjects who doesn't recive rescue analgesic | 0~72 hours after administration |
Countries
China
Outcome results
None listed