Postoperative pain, long-acting amide local anesthetics
Conditions
Interventions
The 200mg QP-6211 dose group:Local infiltration anesthesia was performed with 200mg QP-6211
The 400mg QP-6211 dose group:Local infiltration anesthesia was performed with 400mg QP-6211
The placebo group:Local infiltration was performed with 0.9% sodium chloride injection
Positive control group:Local infiltration anesthesia was performed with 75 mg ropivacaine 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 purpose, nature, methods and possible adverse reactions of the study, voluntarily participate in the study and sign the informed consent; 2. The subjects with grade ?-? internal hemorrhoids, external hemorrhoids or mixed hemorrhoids with prolapse were planned to undergo external stripping and internal ligation under subarachnoid anesthesia, and the number of incisions was expected to be =2. 3. Subjects with American Society of Anesthesiologists (ASA) grade I-II; 4. 18 years old = age =75 years old, regardless of gender; 5. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (including 18.0 and 30.0 kg/m2), body weight of male subjects should not be less than 50 kg, and body weight of female subjects should not be less than 45 kg; 6. Able to communicate well with investigators, understand the requirements of this trial and the use of NRS pain scale and satisfaction rating scale.
Exclusion criteria
Exclusion criteria: 1. Subjects who have a history of allergy to or contraindication to amide local anesthetics such as ropivacaine or any excipients of QP-6211 or other drugs that may be used during the trial; 2. Subjects who are not suitable for subarachnoid anesthesia, such as existing spinal cord or severe spinal lesions; (3) Patients with any of the following diseases or conditions within 1 year before randomization: heart failure (NYHA class III or IV), unstable angina, history of myocardial infarction, pulmonary heart disease, or severe arrhythmia; 4. subjects with previous history of hemorrhoidectomy; 5. Subjects with constipation (defined as less than three bowel movements per week) within 30 days before randomization; 6. Patients with fecal incontinence, perianal abscess, anal fistula, anorectal prolapse, portal hypertension with rectal varices, and inflammatory bowel disease (ulcerative colitis and Crohn's disease) who were judged by the investigators to be not suitable for the trial; 7. Patients who had undergone another surgical procedure within 3 months before randomization or who were scheduled to undergo another surgical procedure during the trial; 8. Subjects with other pain that may confound the postoperative pain assessment according to the investigator's judgment; 9. Subjects with cerebral ischemic diseases (ischemic stroke or transient ischemic attack), seizures and other central nervous system or mental system diseases (such as schizophrenia, depression, etc.) and cognitive impairment, which affect the efficacy evaluation of the trial drug according to the investigator's judgment; 10. History of severe or refractory postoperative nausea or vomiting; 11. Subjects who used other drugs that were judged by the investigator to affect the evaluation of analgesic efficacy in the 5 half-lives before randomization (based on the actual drug instructions, or 7 days before randomization if the half-lives were not clear), including but not limited to: Opioids, local anesthetics (including bupivacaine), NSAIDs, glucocorticoids (except aerosol inhalation and topical application), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), 5-HT and NE reuptake inhibitors (SNRIs) and other antidepressants, antiepileptic and anticonvulsant drugs such as gabapentin and pregabalin, etc. Sedatives and hypnotics such as thiopentone and nitrazepam, other analgesics (such as clonidine), other drugs affecting the evaluation of hemorrhoid pain (such as diosmin); 12. Drugs affecting liver metabolism: strong CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, eylestradiol) during the first 5 half-life periods of randomization; 13. Abnormal vital signs, physical examination, 12-lead electrocardiogram, and laboratory findings during screening that were judged by the investigator to be ineligible for the trial included: a) subjects whose blood pressure is poorly controlled on medical therapy: systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg; Or systolic blood pressure ULN prolongation for 3 seconds and/or activated partial thromboplastin time (APTT) > ULN prolongation for 10 seconds; c) Liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =3x ULN; Total bilirubin (TBIL) =2x ULN; Albumin (ALB) < 30 g/L; d) renal function: serum creatinine (Cr) =1.5x ULN; e) QTcF=450 msec in men and =470 msec in women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjects' overall satisfaction with analgesia was scored;Investigator's overall satisfaction with analgesia;Peak concentration of ropivacaine;Consumption of opioids;Proportion of subjects who did not use opioids; | — |
Countries
China
Contacts
Public ContactWen Ouyang
The Third Xiangya Hospital of Central South University
Outcome results
None listed