Lung diseases
Conditions
Interventions
Sponsors
Chengdu Second People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Hospitalized patients aged 18 to 65 years old were screened, male or female; (2) patients undergoing elective thoracoscopic lobectomy or sublobectomy under general anesthesia, with expected operation time of 1h-4 hours, and expected to require patient-controlled intravenous analgesia (PCEA) for more than 48 hours after surgery (moderate to severe pain); (3) Tracheal intubation under general anesthesia, ASA classification ?-?; (4) 18kg/m2<= body mass index (BMI)=30kg/m2; (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 NRS-11 score and cooperate with the evaluation; (2) severe respiratory depression, such as oxygen saturation under inspired air less than 90%; (3) patients with acute or severe bronchial asthma, chronic obstructive pulmonary disease or pulmonary heart disease; (4) patients with known or suspected biliary colic, biliary obstruction or intestinal obstruction, including paralytic intestinal obstruction; (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 80×109/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 previously known to be allergic to opioids, such as tigelilidine fumarate and morphine; (19) pregnant and lactating women; (20) patients with narcotic drug dependence or opioid tolerance before screening; (21) a history of drugs, substance abuse or alcohol abuse prior to screening (i.e., drinking more than 14 units of alcohol per week (1 unit =360
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who did not use rescue analgesics from 0 to 48 h after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric rating scale (NRS) was used to evaluate pain at 0.5 h, 2 h, 6 h, 12 h, 24 h and 48 h after operation;Analgesic pump usage (pressing times, drug usage);Incidence of pulmonary complications within 48 hours after surgery;The incidence of moderate to severe nausea and vomiting within 48 hours after surgery was recorded;Incidence of PONV= grade 2 within 48 h after surgery;Postoperative bowel sound recovery, exhaust recovery and defecation recovery time;The time of first need for analgesics after surgery and the amount of rescue opioids used after surgery;Richards-campbell sleep Questionnaire (RCSQ) score on the day of surgery and the first day after surgery;QoR-15 score at 24 h and 48 h after operation;The time of leaving recovery room, postoperative ambulation time, chest drainage tube removal time, first ambulation time and hospital stay were recorded;Incidence of chronic pain at 1 month after surgery; | — |
Countries
China
Contacts
Public ContactMan Yang
Chengdu Second People’s Hospital
Outcome results
None listed