Patients with grade III and IV hemorrhoid surgery
Conditions
Interventions
Diltiazem hydrochloride gel experimental group:2% diltiazem hydrochloride gel was added for postoperative analgesia under the maintenance of routine postoperative treatment
Conrol group:blank gel free of medicinal ingredients
Sponsors
Zhejiang Xiaoshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.The subject can understand the procedures and methods of the clinical trial (including the pain intensity assessment method), and voluntarily participate in the clinical trial with full informed consent signed by the subject; 2.When signing the informed consent, the age of 18 <=65 years old, with no gender limitation; 3.Patients with grade III or IV internal hemorrhoids (Goligher's classification), or external hemorrhoids, or mixed hemorrhoids, who are scheduled for external dissection and internal ligation (Milligan Morgan surgery); 4.Female or male subjects of reproductive age shall agree to take effective contraceptive measures for themselves and their partners within 30 days after signing informed consent to the end of medication.
Exclusion criteria
Exclusion criteria: 1.Complicated with other anal diseases, such as anal fissure, anal fistula, hemorrhoids thrombosis, perianal abscess, rectal polyps, anal papilloma; 2.Simultaneous sphincterotomy is required; 3.Medical conditions unrelated to hemorrhoidectomy (e.g., rheumatoid arthritis, chronic neuropathic pain, concomitant vasectomy) or intraoperative pain may confuse the evaluator of postoperative pain; 4.Those who have a history of or are currently suffering from any of the following clinically serious diseases: (1)Respiratory diseases: such as acute or bronchial asthma, pulmonary heart disease, other chronic lung diseases or a history of respiratory depression; (2)Neuropsychiatric diseases: such as craniocerebral injury, increased intracranial pressure, history of depression, anxiety, epilepsy (including the history of high fever and convulsion in childhood), other brain diseases or mental state diseases that affect self-evaluation ability, etc.; (3)Circulatory diseases:Patients with or without symptoms of ischemic heart disease, stable angina, unstable angina, or myocardial infarction within the last 6 months, heart failure (class iii-iv according to the New York heart association [NYHA] classification), or poorly controlled hypertension (systolic blood pressure>= 160mmHg or diastolic blood pressure >= 90mmHg); (4)Diseases of the blood system: bleeding diseases caused by coagulation factor defects or other coagulation index disorders; (5)digestive system diseases: such as known gastrointestinal bleeding, gastrointestinal obstruction or perforation and other irritation of the gastrointestinal tract may cause dangerous diseases; (6)There are other diseases or disease history that may significantly affect the safety evaluation or in vivo metabolism of the test drug; 5.Currently using calcium channel blockers; 6.Previous use of calcium channel blockers has clear side effects; 7.Allergic to diltiazem; 8.Allergic to analgesics (parecoxib) that may be used after surgery; 9.Those who cannot quit smoking or alcohol (except for therapeutic drugs containing alcohol) from 48 hours before surgery to 72 hours after the end of medication; 10.Use of opioids or opioids within 2 weeks prior to surgery; 11.Preparations, tricyclic antidepressants, antipsychotics, serotonin, norepinephrine reuptake Inhibitors (SNRI), muscle relaxants and anticholinergic drugs 12.3 months prior to administration (regular drinkers within 90 days, i.e. drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45mL 40% alcohol spirits or 150mL wine); 13.Within 3 months (90 days) before administration, patients underwent major surgery on overweight patients or underwent surgery that could significantly affect the in-vivo process or safety evaluation of the study drug; 14.Patients with a history of substance abuse, needlesickness or blood sickness, or who cannot tolerate blood collection by venipunction; 15.pregnant women and breast-feeding women who are currently breast-feeding or who have not been artificially breast-feeding but are less than 6 months after delivery; 16.The investigator considers that the efficacy will not be evaluated or the expected course of treatment and follow-up are unlikely to be completed and other conditions are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;NRS scores for pain at rest;NRS score for pain at first defecation; | — |
Countries
China
Contacts
Public ContactFan Zhikun
Outcome results
None listed