Postoperative moderate to severe pain in patients undergoing gynecological laparoscopic surgery
Conditions
Interventions
Group TB1:low dose Tegileridine Combined with Butorphanol
Group TB2:Conventional dose Tegileridine Combined with Butorphanol
Group T:Conventional dose Tegileridine
Sponsors
Chinese People's Liberation Army Northern Theater Command General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Accept gynecological laparoscopic surgery under elective general anesthesia, with a surgical duration of >= 1.5 hours; 2. Age between 18 and 65 years old; 3.18 kg/m^2= 4 points at any time in a resting state; 6. Before starting any activities related to the experiment, voluntarily sign an informed consent form, fully understand the purpose and significance of the experiment, and voluntarily follow the experimental procedures.
Exclusion criteria
Exclusion criteria: 1. History of difficult airway (obstructive sleep apnea syndrome) in the past; 2. Patients with severe respiratory depression such as oxygen saturation below 90% or a history of acute or severe bronchial asthma; 3. Subjects with a history of serious cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina, or a history of severe arrhythmias such as grade II or above atrioventricular block, or a history of NYHA heart function grade II or above, ischemic stroke); 4. Subjects with hypertension or hypotension who have not received formal antihypertensive treatment or have poor blood pressure control (screening period systolic blood pressure >= 160mmHg or = 100mmHg or <= 60mmHg), excluding abnormalities during the period from anesthesia induction to exit the recovery room; 5. Known or suspected gastrointestinal obstruction, including patients with paralytic intestinal obstruction; 6. Patients who are allergic to any component of opioid drugs or experimental drugs; 7. Subjects with previous mental system disorders (such as schizophrenia, depression, etc.) and cognitive impairment; 8. Subjects with advanced malignant tumors or malignant tumors with extensive metastasis; 9. Merge subjects with other physical pain that may affect postoperative pain assessment; 10. Have a history of drug abuse, drug use, and/or alcohol abuse within the past year prior to randomization; 11. Pregnant or lactating female subjects; 12. Participants who are deemed unsuitable by the researchers to participate in this trial due to any other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| resting pain intensity within 48 hours after starting injection of investigational drug (SPID48); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time weighted sum of pain intensity differences between resting and exercise states at 10 min, 30 min, 6 h, 12 h, 24 h, and 36 h, and time weighted sum of pain intensity differences between exercise states at 48 h;Weighted sum of pain relief scores for resting and exercise states at 10 min, 30 min, 6 h, 12 h, 24 h, and 12-24 h (TOTPAR1/6, TOTPAR0.5, TOTPAR6, TOTPAR12, TOTPAR24, TOTPAR12-24);The proportion of subjects who used salvage analgesia within 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours, and 36-48 hours after surgery, the number of times salvage analgesia was used, and the cumulative amount of salvage analgesic drugs used;The time of first use of salvage analgesics within 48 hours after surgery;Total and effective compressions of PCA pump from 0-24 hours and 24-48 hours after surgery;The incidence and frequency of PONV and itching at 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours, and 36-48 hours after surgery;Postoperative PONV Visual Analog Scale (VAS) at 10 min, 30 min, 6 h, 12 h, 24 h, 36 h, and 48 h;The dosage of antiemetic medication after surgery, the duration of the first time getting out of bed Total length of hospital stay and patient pain relief satisfaction score; | — |
Countries
China
Contacts
Public ContactYugang Diao
Chinese People's Liberation Army Northern Theater Command General Hospital
Outcome results
None listed