Postoperative pain
Conditions
Interventions
experimental group:Oral administration Tapentadol Hydrochloride tablets
Control Group:Oral administration Oxycodone hydrochloride capsules
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Agree to participate in the study and sign informed consent; 2) Patients undergoing elective orthopedic surgery (including unilateral hip replacement, unilateral knee replacement, unilateral knee ligament reconstruction, unilateral shoulder replacement, unilateral rotator cuff repair and other hip, knee or shoulder joint surgery), the anesthesia method was general anesthesia or single spinal anesthesia; 3) Male or female aged =18 and =75 years old; 4) ASA grade =III; 5) Body mass index (BMI) between 18-30kg/m2 (including cutoff values); 6) Modified Mahalanobis score < III; 7) NRS =4 (rest pain) within 6h after analgesia pump cessation.
Exclusion criteria
Exclusion criteria: 1) Patients with acute or chronic pain (3 consecutive months or 6 consecutive months) related to non-surgical sites; 2) Patients with respiratory depression or high risk of respiratory depression (such as sleep apnea syndrome, bronchial asthma, etc.); 3) Patients with preoperative uncontrolled gastrointestinal ulcer or bleeding or other gastrointestinal diseases affecting drug absorption; Or paralytic ileus; 4) Patients with previous craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, or central nervous system diseases (such as epilepsy); 5) Patients with psychiatric disorders (such as depression) or long-term use of psychotropic drugs; 6) Patients with evidence of severe heart failure (NYHA class III or IV), unstable angina or acute myocardial infarction, severe arrhythmia, heart failure, degree II-III atrioventricular block, or refractory hypertension (requiring three or more antihypertensive drugs to control blood pressure) within 6 months before screening; 7) Patients with a history of opioid allergy or allergy to intraoperative medication or postoperative rescue analgesic or antiemetic drugs prescribed by the protocol; 8) Patients had a history of drug abuse, alcohol abuse, or drug abuse within 2 years before screening. Alcohol abuse was defined as regularly drinking more than 14 units/week (1 unit =150 mL wine, 360 mL beer, or 45 mL liquor). 9) Use of intra-articular or systemic steroids (except inhaled and topical steroids) within 3 months before screening; The use of long-acting or controlled-release opioids within 30 days before screening, drugs that affect analgesic effect with unclear half-failure period; Use of monoamine oxidase inhibitors or serotonin-and norepinephrine reuptake inhibitors within 2 weeks before screening; The use of short-acting opioids or other drugs that affect analgesia less than 5 half-lives before randomization (excluding medications specified in the protocol); 10) Enrolled as a subject in any drug clinical trial within 3 months before screening; 11) Pregnant or lactating women, or those with a positive pregnancy test in blood (or urine) at screening or on the day of surgery, and those (including men) who do not consent to contraception during the study and within 3 months after surgery, or who have plans to donate eggs and sperm; 12) Clinically significant abnormal liver and kidney function (ALT or AST > 1.5 times the upper limit of normal; BUN or Urea >1.5 times the upper limit of normal; Cr > limit of normal; Dialysis within 28 days before surgery), or abnormal coagulation function (PT or APTT or TT > limit of normal), or SBP 8.8mmol/L, or oxygen saturation (without oxygen) < 94%; 13) Intraoperative or postoperative protocol deviations (including the use of banned drugs) that may affect the efficacy and safety evaluation in the study; 14) Evidence of hemodynamic instability or respiratory insufficiency; 15) Patients with blood loss more than 1000mL or other serious complications during the operation; 16) Requiring intensive care after surgery; 17) Patients with severe nausea and/or vomiting (PONV=7) who were judged by the investigator to be not suitable for enrollment; 18) Other investigators judged that participation was not appropriate (explain the reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject satisfaction score; | — |
Countries
China
Contacts
Public ContactWen Ouyang/SaiYing Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed