Postoperative pain after ophthalmic surgery
Conditions
Interventions
Group Nalbuphine:Intravenous nalbuphine administered before the end of surgery for postoperative analgesia
Group Anrikefon:Intravenous anrikefon administered before the end of surgery for postoperative analgesia
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Scheduled for ophthalmic surgery under general anesthesia; 2.Aged 18 to 70 years; 3.American Society of Anesthesiologists (ASA) physical status I to III; 4.Body mass index (BMI) between 18 and 30 kg/m^2; 5.Agree to participate in the trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.A history of cardiovascular or cerebrovascular events within the past 6 months, including unstable angina, ischemic myocardial infarction, heart failure, or current presence of uncontrolled hypertension (>180/110 mmHg), aneurysm, or severe cardiac arrhythmias; 2.Severe respiratory diseases such as pulmonary fibrosis, severe pulmonary abscess, cor pulmonale, or advanced chronic obstructive pulmonary disease (COPD); 3.Significant neurological disorders such as brain injury or seizures, as well as severe psychiatric illnesses; 4.Known allergy to kappa-opioid receptor agonists or to general anesthetic agents used in this study; 5.Current peptic ulcer disease, gastrointestinal bleeding, or known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), such as flurbiprofen axetil or acetaminophen; 6.Prior use of opioid or non-opioid analgesics, with the last administration occurring within five half-life periods of the drug; 7.Continuous use of opioid analgesics for more than 10 days within the 3 months prior to screening; 8.Use of drugs with unknown half-life periods that may affect analgesic efficacy within 14 days before randomization; 9.History of major surgery within the past 3 months that may interfere with postoperative pain assessment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative NRS pain scores at rest and the time-weighted AUC within 6 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative NRS pain scores and time-weighted AUC during eye movement within 6 hours postoperatively, as well as at rest and during eye movement within 12 and 24 hours postoperatively;NRS scores at rest and during eye movement;Mechanical pain threshold of the operative eye at 2 and 24 hours postoperatively;Ophthalmic examination, including intraocular pressure (IOP), orbital pressure, best-corrected visual acuity (BCVA), and uncorrected visual acuity (UCVA), among others.;Incidence of postoperative complications in the PACU and within 24 hours postoperatively;Cumulative consumption of rescue analgesics (flurbiprofen axetil in the PACU and paracetamol after discharge from the PACU) within 6, 12, and 24 hours postoperatively, as well as the time to first use;Postoperative 24-hour recovery quality assessed using the 15-item Quality of Recovery questionnaire (QoR-15);Satisfaction score of analgesia within 24 hours postoperatively;Recovery time, PACU length of stay, time to first ambulation, time to first oral intake, and postoperative hospital stay;Percentage of patients not requiring rescue analgesics; | — |
Countries
China
Contacts
Public ContactGan Xiaoliang
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed