Postoperative analgesia
Conditions
Interventions
HYR-PB21 test group:At the end of the operation, the perianal block technique was used to inject 5mL of drugs at different locations around the anus and fan into the perianal tissue around the anus (o
Bupivacaine hydrochloride injection control group:At the end of the operation, the perianal block technique was used to inject 5mL of drugs at different locations around the anus and fan into the peri
Placebo group:At the end of the operation, the perianal block technique was used to inject 5mL of normal saline at different locations around the anus and fan into the perianal tissue around the anus
Sponsors
Beijing Chaoyang Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The subject is able to understand the procedures and methods of the clinical trial (including pain intensity assessment methods), has fully informed consent, voluntarily participates in the trial and has the informed consent signed by the subject himself or his legal guardian; (2) When signing the informed consent, age = 18 years old =75 years old, gender is not limited; (3) Male weight =50kg, female weight =45kg, and body mass index (BMI) between 19.0 and 30.0kg/m2 (including the cut-off value); (4) The subject is graded I-III according to the American College of Anesthesiologists (ASA) classification criteria; (5) It is planned to perform hemorrhoidectomy (PPH) with stapler under general anesthesia for patients with mixed hemorrhoids dominated by internal hemorrhoids, and the cumulative incision length is =3cm; (6) Female or male subjects of reproductive age must agree to use effective contraception for themselves and the male subject's partner within 30 days after signing the informed consent form to the medication.
Exclusion criteria
Exclusion criteria: (1) People who are allergic to or have a history of special reactions to amide local anesthetics (such as lidocaine, bupivacaine, ropivacaine, etc.), opioids, or any component of the drugs used in this trial, or who are allergic to two or more drugs, foods, or pollen; (2) Medical conditions unrelated to hemorrhoidectomy or pain associated with surgery (e.g., rheumatoid arthritis, chronic neuropathic pain, concomitant vasectomy, etc.) that may confuse the postoperative pain evaluator; (3) Patients who have a history of any of the following clinical serious diseases or are currently suffering from serious diseases that are determined by the investigator (physician) to affect this study: ? Respiratory diseases: such as severe lung infection, acute attack of bronchial asthma or a history of respiratory depression; (2) Neuropsychiatric diseases: such as craniocerebral injury, elevated intracranial pressure, depression, anxiety, epilepsy history (including a history of febrile convulsions in childhood), other brain diseases or mental state diseases that affect self-evaluation ability; Circulatory diseases: such as pulmonary heart disease, unstable angina and/or myocardial infarction within the last 6 months, patients with heart failure (class IIY-IV according to the New York Heart Association [NYHA]) or poorly controlled hypertension (systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg) after medication; (4) Blood system diseases: bleeding diseases caused by coagulation factor defects or other coagulation index disorders; (5) Digestive system diseases: such as known bleeding of the digestive system, gastrointestinal obstruction or perforation, and other diseases that may cause danger to the gastrointestinal tract; The presence of other diseases or disease histories that may significantly affect the safety evaluation or metabolism of the investigational drug. (4) Laboratory test results during the screening period meet the following requirements: Hemoglobin (Hb) =80g/L; ? Platelet count (PLT) =50×109/L; ? Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2 times the upper limit of normal value; ? Serum creatinine (Cr) = 1.5 times the upper limit of normal value; Creatinine clearance 7.8mmol/L; ? Prothrombin time (PT) > upper normal value +3s or partially activated thrombin time (APTT) > upper normal value +10s. (5) The QTcF interval was significantly prolonged (for example, the QTcF interval was > 450ms for the first check during the screening period, and the value of three consecutive checks was > 450ms, or the average value of three checks was > 450ms); The presence of other risk factors for TdP (e.g., heart failure, hypokalemia, bradycardia, hereditary long QT syndrome) that the investigator determined affected this trial; Use drugs that cause prolonged QT/QTc intervals (QTcF intervals are calculated using the Fridericia formula); (6) Those who have a positive virological test (hepatitis B E antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody) before or during screening; (7) any analgesic drugs (such as non-steroidal anti-inflammatory drugs, oxycodone, ketorolac, ketoprofen, diclofenac or pregabalin, etc.) that may or are planned to be used within 12 hours before or during surgery; (8) Those who cannot quit smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS AUC0-72h; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total amount of remedial drug used (based on oral morphine equivalent) within 0-72 hours after the end of administration;Proportion of subjects receiving =1 dose of the remedy within 0-72 hours after the end of dosing;Time of first use of remedial analgesics after surgery;Resting pain NRS score at different time periods after administration - area under the curve;Proportion of subjects with resting pain NRS score =1 score within 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 60h and 72h after administration;NRS pain score at first postoperative defecation;NRS pain score at first postoperative dressing change;Subjects' satisfaction with postoperative analgesia; | — |
Countries
CHINA
Contacts
Public ContactZhenjun Wang
Beijing Chaoyang Hospital of Capital Medical University
Outcome results
None listed