Myoma of uterus
Conditions
Interventions
Sponsors
Chengdu Second People’s Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Inpatients aged 18 to 65 years old were screened; 2. patients scheduled for laparoscopic myomectomy under general anesthesia with expected operation time of 1h-4h and expected to require patient-controlled intravenous analgesia (PCEA) for more than 48h after operation; 3. ASA anesthesia grade ?-II; 4. 18kg/m^2<= body mass index (BMI)<=30kg/m^2; 5. The subjects fully understood the purpose, content, process and risks of the trial, voluntarily participated in the clinical trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. unable to understand and cooperate with NRS-11 score; 2. combined inhalation injury, burn shock, and organ injury after burn 3. patients with severe respiratory depression, such as oxygen saturation below 90% under inspired air; 4. patients with acute or severe bronchial asthma, chronic obstructive pulmonary disease or pulmonary heart disease; 5. patients with hypothyroidism and cortical insufficiency; 6. patients with prostatic hypertrophy and dysuria; Subjects with sensory disorders such as hyperalgesia; 7. subjects with other body pain that may affect postoperative pain assessment; 8. combined with airway or spinal anatomical factors of ventilation disorders, severe thoracic adhesion on the surgical side, etc. 9. patients with a history of head trauma, intracranial surgery, or stroke within 4 weeks before surgery, or with organic lesions of the central nervous system or disturbance of consciousness, which may affect the evaluation of drug efficacy according to the investigator; 10. patients with high bleeding risk, including patients with congenital bleeding disorders such as hemophilia, thrombocytopenia (platelet count less than 80×10^9/L), coagulation disorders (PT prolongation exceeding 3 seconds or APTT prolongation exceeding 10 seconds), or diseases related to abnormal platelet function; 11. any of the following specific abnormal laboratory screening values: ALT and/or AST>2 times the upper limit of normal; BUN>2 times upper limit of normal (ULN), or Cr> ULN; Hb =160mmHg or DBP>=100mmHg) after regular antihypertensive treatment, and investigator's assessment of the impact on the safety of the trial; 13. history of gastrointestinal ulcer or bleeding within 2 years before surgery; 14. Within 6 months before screening, the following cardiovascular and cerebrovascular events occurred: Acute coronary syndrome, coronary-artery bypass grafting, percutaneous coronary intervention (other than diagnostic angiography), congestive heart failure (New York Heart Association [NYHA] class III or IV), major or medically required arrhythmia, cerebrovascular accident (including TIA episodes); 15. patients with serious primary diseases such as blood system, serious mental or nervous system diseases or serious sleep disorders, long-term or within 7 days before randomization, who took antipsychotic, anticonvulsant or hypnotic drugs, and affected the test evaluation by the researchers; 16. Use of opioid agonist/antagonist or other drug/treatment affecting analgesia within 24h before randomization (or within 5 half-lives of the drug label), Including, but not limited to, ibuprofen, acetaminophen or other non-steroidal anti-inflammatory drugs (NSAIDs), monoamine oxidase inhibitors, glucocorticoids (except topical and inhaled drugs), sedative drugs; 17. the use of traditional Chinese medicine or Chinese patent medicine mainly used for analgesic effect within 7 days before randomization, which affected the trial evaluation by the investigator; 18. patients with previous known allergies to opioids, such as tygelidine fumarate, morphine, etc.; 19. pregnant and lactating women; 20. patients with narcotic drug dependence or opioid tolerance before screening; 21. having a history of drug or drug abuse or alcohol abuse before screening (i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); 22. patients with other conditions deeme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time required for the first postoperative flatus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time required for the first postoperative defecation;Time of the first oral intake after surgery;Postoperative nausea and vomiting (PONV) within 48 hours;The time-weighted sum of pain intensity differences in the resting state within 48 hours after the operation (SPID48);The patient's satisfaction score for pain relief treatment;The QoR-15 scores at 24 hours and 48 hours after the operation; | — |
Countries
China
Contacts
Public ContactKeyu Xie
Chengdu Second People’s Hospital
Outcome results
None listed