Pain
Conditions
Interventions
Low dose group:Local injection of GBI268 injection 7mL (containing bupivacaine/meloxicam about 200 mg/6 mg)
Medium-dose group:Local injection of GBI268 9mL (containing bupivacaine/meloxicam about 260 mg/7.8 mg)
High dose group:Local injection of GBI268 10.5mL (containing bupivacaine/meloxicam about 300mg /9mg)
Positive control group:Local injection of bupivacaine hydrochloride injection 75mg
Placebo control group:Local injection of 0.9% sodium chloride injection 9mL
Sponsors
The Third Xiangya Hospital of Central South University
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subjects were able to understand the procedures and methods of this clinical trial (including the method of pain intensity assessment), and voluntarily participated in the clinical trial with full informed consent signed by the subjects themselves or their legal guardians. 2. When signing the informed consent, 18=50.0kg for men, >=45.0kg for women, and body mass index (BMI) between 19.0 and 30.0kg/m^2 (including cut-off values); 4. Patients with internal hemorrhoids (grade II-III) and mixed hemorrhoids (the number of hemorrhoids >=2, and the cumulative incision length of external hemorrhoid resection tissue =3cm) who planned to undergo external stripping and internal ligation; 5. Subjects with American Society of Anesthesiologists (ASA) grade I-III; 6. Female or male subjects of childbearing age must agree to use effective contraceptive measures by themselves and their partners within 30 days after signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to or contraindicated to amide local anesthetics (such as lidocaine, bupivacaine, ropivacaine, etc.), non-steroidal anti-inflammatory drugs (such as meloxicam, etc.), opioids (such as morphine, etc.) or any component of the drugs used in the trial; 2. Subjects who used other drugs that were judged by the investigator to affect the evaluation of analgesic efficacy within 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), non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids (except nebulized inhalation and topical application), antidepressants (such as monoamine oxidase inhibitors [MAOIs], tricyclic antidepressants [TCAs], 5-HT and NE reuptake inhibitors [SNRIs], etc.), antiepileptic and anticonvulsant drugs (Gabapentin, pregabalin, etc.), sedative hypnotics (sodium thiopental, nitrazepam, etc.), other analgesics (clonidine), and other drugs affecting the evaluation of hemorrhoids pain; 3. patients with severe cerebrovascular disease (such as ischemic stroke, transient ischemic attack, etc.), circulatory system (such as pulmonary heart disease, unstable angina and/or myocardial infarction in the past 6 months, heart failure [according to the New York Heart Association classification of III-IV patients]), blood system (such as coagulation factor deficiency or other coagulation index disorders Hemorrhagic diseases, etc.), central nervous system (such as seizures, etc.), mental system (such as schizophrenia, etc.), cognitive dysfunction, digestive system (such as known gastrointestinal bleeding, gastrointestinal obstruction or perforation, and other diseases that may cause danger by stimulating the gastrointestinal tract, severe or refractory nausea or vomiting history, etc.) and other system diseases. Those who were judged by the investigators to be unfit for the trial; 4. 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; 5. Concomitant medical conditions unrelated to hemorrhoidectomy or pain associated with surgery (e.g., rheumatoid arthritis, chronic neuropathic pain, concomitant vasectomy, etc.), which may be confused by postoperative pain assessors; 6. patients with other diseases or diseases history that may significantly affect the safety evaluation or metabolism of the trial drug. 7. If the screening results meet the following criteria: (1) Hemoglobin (Hb) = 2 times the upper limit of normal value, and/or total bilirubin (TBIL) >= 1.5 times the upper limit of normal value; (4) Serum creatinine (Cr) >= 1.5 times the upper limit of normal; (5) random blood glucose > 11.1mmol/L; (6) Prothrombin time (PT) > upper limit of normal +3s or activated partial thrombin time (APTT) > upper limit of normal +10s; (7) Poor control of hypertension after drug treatment (systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg); (8) Prolonged QTcF interval (e.g., QTcF interval > 450ms in the first examination during the screening period, and the values of three consecutive examinations were > 450m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of resting pain score within 72 hours after the end of administration (AUC0-72 hours); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first use of postoperative rescue analgesic after the end of dosing;After the end of the administration, the total amount of postoperative rescue analgesic was used within 0-24h, 0-48h, and 0-72h;The proportion of subjects who used postoperative rescue analgesics within 0-24h, 0-48h, and 0-72h after the end of the drug administration;Resting NRS score -area under curve at 4h, 8h, 12h, 24h, 36h, 48h, and 60h after the end of dosing;The NRS pain score was scored during the first defecation within 72 hours after surgery;The NRS pain score was scored at the first dressing change within 72 hours after surgery.;Subjects' satisfaction with postoperative analgesia was scored; | — |
Countries
China
Contacts
Public ContactSaiying Wang/ Donglin Ren
The Third Xiangya Hospital of Central South University The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed