Postoperative Analgesia
Conditions
Interventions
Group 1:QP-6211 for Injection
Group 2:sodium chloride injection
Group 3:bupivacaine hydrochloride injection
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the study objectives, nature, methodology, and potential adverse reactions, voluntarily participate in this study, and sign the informed consent form (ICF); 2. Subjects with grade III-IV internal hemorrhoids, external hemorrhoids, and/or mixed hemorrhoids with prolapse, scheduled to undergo hemorrhoidectomy (external dissection and internal ligation) under spinal anesthesia, with anticipated number of incisions >=2; 3. Subjects classified as American Society of Anesthesiologists (ASA) Physical Status Class I-II (refer to Appendix 4 for scoring criteria); 4. Aged >=18 to <75 years, regardless of gender; 5. Body mass index (BMI) between 18.0 and 30.0 kg/m² (inclusive); 6. Capable of effective communication with investigators and able to comprehend study requirements, including the use of Numerical Rating Scale (NRS) and satisfaction assessment scale.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of allergy or contraindications to amide-type local anesthetics (e.g., ropivacaine), opioids, or other medications that may be used during the trial. 2. Subjects unsuitable for spinal anesthesia, such as those with current spinal cord or severe spinal disorders. 3. Subjects with severe cerebrovascular, hepatic, renal, respiratory, hematological, lymphatic, endocrine, immune, neurological, psychiatric, or gastrointestinal diseases, as determined by the investigator to be ineligible for participation. 4. Subjects with any of the following conditions within 1 year before randomization: heart failure (NYHA Class III or IV), unstable angina, myocardial infarction, cor pulmonale, or severe arrhythmias. 5. Subjects with a history of hemorrhoidectomy. 6. Subjects with fecal incontinence, perianal abscess, anal fistula, anorectal prolapse, portal hypertension with rectal varices, or inflammatory bowel disease (ulcerative colitis or Crohn's disease), as determined by the investigator to be ineligible for participation. 7. Subjects who underwent other surgical procedures within 3 months before randomization that may affect trial safety or efficacy evaluation, as judged by the investigator, or those scheduled for concurrent surgeries during the trial. 8. Subjects with other pain conditions that may confound postoperative pain assessment, as determined by the investigator. 9. Subjects with cerebral ischemic diseases (ischemic stroke or transient ischemic attack), epilepsy, central nervous system or psychiatric disorders (e.g., schizophrenia, depression), or cognitive impairment, as determined by the investigator to affect the evaluation of the investigational drug's efficacy. 10. Subjects with a history of severe or refractory postoperative nausea or vomiting. 11. Subjects who used medications judged by the investigator to interfere with analgesic efficacy evaluation within 5 half-lives before randomization (or within 7 days if the half-life is unknown, based on the drug's prescribing information). 12. Subjects who used strong CYP1A2 inhibitors within 5 half-lives before randomization. 13. Subjects with abnormal vital signs, physical examination, 12-lead ECG, or laboratory test results during screening, as determined by the investigator to be ineligible for participation. 14. Subjects who are HIV antibody (HIV-Ab) positive and/or Treponema pallidum antibody (TP-Ab) positive. 15. Female subjects with a positive blood pregnancy test or who are breastfeeding; subjects of childbearing potential unwilling/unable to use effective contraception or planning pregnancy/donate sperm/eggs during or within 3 months after the trial. 16. Subjects who consumed >14 units of alcohol per week within 3 months before randomization (1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine). 17. Subjects unwilling to abstain from smoking and/or alcohol during the trial. 18. Subjects who participated in any drug or medical device clinical trial within 1 month before randomization. 19. Other conditions deemed by the investigator to make the subject unsuitable for participation..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS-R-AUC within 72 hours after the initiation of drug administration: AUC0-72h; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total morphine consumption; | — |
Countries
China
Contacts
Public ContactOuyang Wen; Wang Saiying
The Third Xiangya Hospital of Central South University
Outcome results
None listed