Postoperative analgesia
Conditions
Interventions
HYR-PB21 low dose test group:HYR-PB21 for injection, 100mg (20ml), was advanced from back to front with a blunt-pointed nerve-blocking needle by an intraplane approach to the standard site of intermus
HYR-PB21 high dose test group:HYR-PB21 for injection, 200mg (20ml), was advanced from back to front with a blunt-pointed nerve-blocking needle by an interplane approach to the standard site of intermu
Bupivacaine hydrochloride control group:Bupivacaine hydrochloride injection, 75mg (20ml), was advanced from back to front using a blunt-pointed nerve blocker via an intraplane approach to the standard
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The subjects are able to understand the procedures and methods of the clinical trial (including the pain intensity assessment method), have fully informed consent, and voluntarily participate in the informed consent signed by the subjects themselves or impartial witnesses; (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) Subjects were classified as class I-III according to the American College of Anesthesiologists (ASA) grading standards; (5) Patients who have indications for rotator cuff repair surgery and plan to undergo unilateral rotator cuff suture repair under arthroscopy under general anesthesia; (6) Male or female subjects of reproductive age must agree to use effective contraception by themselves or their partners for 30 days from the date of signing the informed consent
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) The shoulder of the intended surgical side has a history of previous surgery; (3) Patients with false paralysis or large irreparable rotator cuff tear; (4) Patients who have any of the following clinical serious past history or current serious disease and are determined by the investigator (physician) to affect this study: ? Respiratory diseases: combined with obstructive or restrictive lung diseases; ? 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 (according to the New York Heart Association [NYHA] classification III - IV patients) or poorly controlled hypertension (systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg) after medication; A history of coronary artery bypass within 12 months; ? Blood system diseases: bleeding diseases caused by coagulation factor defects or other coagulation index disorders; ? 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; ? Patients with a history of chronic pain (pain lasting more than three months outside the indications for this surgery, such as trauma, shingles, trigeminal neuralgia, etc.); ?There are other diseases or medical histories that may significantly affect the safety evaluation or metabolism of the test drug. (5) Laboratory test results during the screening period meet the following requirements: ? Platelet count (PLT) =50×10^9/L; ? Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 times the upper limit of normal value; ? Serum creatinine (Cr) = 2 times the upper limit of normal value; ? Prothrombin time (PT) > upper normal value +3s or partially activated thrombin time (APTT) > upper normal value +10s. (6) 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; Or use of drugs that cause prolonged QT/QTc interval within 1 month prior to screening (QTcF interval calculation using the Fridericia formula); (7) Those who are positive in virological examination (hepatitis B E antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody) during the screening period; (8) The patient, due to the needs of the treatment plan, plans to use the analgesic drugs prohibited under this plan within 72 hours after administration; (9) Use of analgesic drugs before surgery (except those who have stopped using 7 drug half-lives (with a definite half-life) or more than 2 weeks (without a defi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS AUC0-72h; | — |
Secondary
| Measure | Time frame |
|---|---|
| Within 0-72h after the end of administration, the total amount of remedial drugs used (calculated according to intravenous morphine equivalent);Proportion of subjects who did not use remedial drugs within 0-72 hours after the end of administration;The time of first use of remedial drugs after the subject wakes up; | — |
Countries
China
Contacts
Public ContactHailong Dong
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed