Postoperative Pain after Laparoscopic Hysterectomy
Conditions
Interventions
Tegilerdin Group (Group T):Postoperative analgesia achieved with Tegilerdin
Morphine Group (Group M):Morphine for postoperative analgesia
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Hospitalized patients aged 18 to 65 years (inclusive); 2.Patients scheduled to undergo laparoscopic hysterectomy under general anesthesia, with an expected surgery duration of 1 to 4 hours, and anticipated requirement for patient-controlled intravenous analgesia for over 48 hours postoperatively (for moderate to severe pain); 3.Patients undergoing general anesthesia with endotracheal intubation, classified as ASA physical status I or II; 4.Body mass index (BMI) between 18 kg/m² and 30 kg/m² (inclusive); 5.Patients who fully understand the trial's purpose, procedures, and potential risks, and voluntarily participate in the clinical trial by providing written informed consent.
Exclusion criteria
Exclusion criteria: 1.Inability to comprehend the NRS-11 score or cooperate with pain assessment; 2.Patients with severe respiratory depression, such as oxygen saturation below 90% while breathing room air; 3.Patients with acute or severe bronchial asthma, chronic obstructive pulmonary disease, or cor pulmonale; 4.Patients with known or suspected biliary colic, biliary obstruction, or intestinal obstruction (including paralytic ileus) before surgery; 5.Patients with hypothyroidism or adrenal cortical insufficiency; 6.Subjects with sensory disorders such as hyperalgesia; 7.Subjects with other somatic pain that may interfere with postoperative pain assessment; 8.Patients with ventilatory disorder due to anatomical factors of the airway or spine. 9.Patients with a history of head trauma, intracranial surgery, or stroke within 4 weeks prior to surgery; or those with organic central nervous system diseases or impaired consciousness; or patients deemed by the investigator as unsuitable for drug efficacy evaluation; 10.Patients at high risk of bleeding, including those with congenital bleeding disorders (e.g., hemophilia), thrombocytopenia (platelet count 3 seconds above the upper limit of normal [ULN] or APTT prolonged > 10 seconds above ULN), or a history of diseases related to platelet dysfunction; 11.Any of the following specific abnormalities in laboratory screening values: ALT and/or AST > 2 × ULN; BUN > 2 × ULN, or Cr > ULN; Hb = 160 mmHg or DBP >= 100 mmHg) and assessed by the investigator as posing a risk to trial safety; 13.History of peptic ulcer or gastrointestinal bleeding within 2 years prior to surgery; 14.Within 6 months prior to screening, occurrence of any of the following cardiovascular or cerebrovascular events: acute coronary syndrome, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), congestive heart failure (NYHA Class III or IV), severe or medically significant arrhythmia, cerebrovascular accident (including transient ischemic attack); 15.Patients with severe primary diseases of the hematopoietic system, or severe psychiatric/neurological disorders, or severe sleep disorders; those taking antipsychotic, anticonvulsant, or hypnotic drugs chronically or within 7 days prior to randomization, and assessed by the investigator as affecting trial evaluation; 16.Use of opioid agonists/antagonists within 24 hours prior to randomization (or within 5 half-lives per the drug label), or use of other medications/therapies affecting analgesic efficacy, including but not limited to ibuprofen, acetaminophen, other NSAIDs, monoamine oxidase inhibitors, glucocorticoids (excluding topical and inhaled preparations), or sedative drugs; 17.Use of Chinese herbal medicines or proprietary Chinese medicinal products primarily for analgesic purposes within 7 days prior to randomization, and assessed by the investigator as affecting trial evaluation; 18.Patients with a known history of allergy to opioid drugs, such as Fumarate Tegilerdin, morphine, etc. 19.Pregnant or lactating women; 20.Patients with a history of dependence on narcotic drugs or tolerance to opioid drugs prior to screening; 21.Other conditions considered by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether to use rescue analgesics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Richards-Campbell Sleep Questionnaire (RCSQ) Score;Whether PONV of grade 2 or above occurred;Discharge time;Time to first rescue analgesic administration postoperatively and total consumption of rescue analgesics postoperatively.;Analgesic Pump Utilization (Number of Compressions, Drug Dosage Administered);Numeric Rating Scale (NRS) scores for pain at rest and during activity;The time when the patient left the recovery room, the time when the pelvic drainage tube was removed, and the time of the first out-of-bed activity.;QoR-15 score;Postoperative recovery time of bowel sounds, flatus, and defecation; | — |
Countries
China
Contacts
Public ContactZhou Chen
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed