postoperative pain after laparoscopic gynecological surgery
Conditions
Interventions
Tegileridine Group:Tegileridine Fumarate Injection
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–65 years; 2.Undergoing elective laparoscopic gynecological surgery; 3.American Society of Anesthesiologists (ASA) physical status I–III; 4.Body mass index (BMI) 18–30 kg/m²; 5.Patients agree to participate in this study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Undergoing emergency surgery; 2.Having acute or severe bronchial asthma; 3.Known or suspected gastrointestinal obstruction; 4.History of chronic pain, or regular use of opioids; 5.History of alcohol abuse; 6.History of abdominal surgery within the past 6 months; 7.Unable to understand the study-related rating scales; 8.Allergy to any of the study medications; 9.Deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative area under the curve (AUC) of resting NRS pain scores within 48 hours postoperatively (rAUC0-48h); | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of PCA presses;Time to first bowel movement;Incidence of PONV;I-FEED score;Time to first flatus;Incidence of dizziness;QoR-15 questionnaire score;Severity of postoperative nausea and vomiting (PONV);Cumulative area under the curve (AUC) of NRS pain scores on turning over within 48 hours postoperatively (mAUC0-48h);Adverse events, vital signs (SBP/DBP/MAP, HR, RR, SpO2, BT), 12-lead ECG, laboratory tests (CBC, blood biochemistry, coagulation profile), etc.;Rescue antiemetic and rescue analgesic use (frequency, proportion of patients, and dosage).;The incidence of PONV within 24 hours;NRS pain scores at rest and on turning over.; | — |
Countries
China
Contacts
Public ContactFuhai Ji
The First Affiliated Hospital of Soochow University
Outcome results
None listed