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. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
Interventions
DRUGHR18034
HR18034 low dose
DRUGropivacaine HCl.
ropivacaine HCl.
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
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 ≤ 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
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 | Description |
|---|---|---|
| AUC of Pain Intensity in move state | 0~24 hours，0~48 hours，0~72 hours after administration | AUC of Pain Intensity in move state |
| Pain intensity in rest state assessed using an 11-point NPRS ranging | 0~72 hours after administration | 11-point NPRS ranging from a score of 0 to 10 |
| Pain intensity in move state assessed using an 11-point NPRS ranging | 0~72 hours after administration | 11-point NPRS ranging from a score of 0 to 10 |
| AUC of Pain Intensity in rest state | 0~24 hours，0~48 hours after administration | AUC of Pain Intensity in rest state |
| 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