Ophthalmic Surgery, Postoperative Pain Management, Opioid Analgesia
Conditions
Brief summary
The goal of this clinical trial is to learn if Anrikefon works as well as nalbuphine to control postoperative pain in adults undergoing ophthalmic surgery under general anesthesia. It will also learn about the safety and recovery outcomes of using Anrikefon. The main questions it aims to answer are: * Does Anrikefon provide pain relief that is not inferior to nalbuphine after ophthalmic surgery? * Does Anrikefon cause fewer central side effects, such as sedation or dizziness, compared with nalbuphine? * Does Anrikefon help patients recover and get discharged faster after day-surgery procedures? Researchers will compare Anrikefon to nalbuphine to see if Anrikefon can offer effective and safer perioperative analgesia for ophthalmic day-surgery patients. Participants will: * Receive either an intravenous dose of Anrikefon or nalbuphine during surgery. * Be monitored for pain scores, side effects, and recovery parameters after surgery. * Complete follow-up assessments.
Interventions
DRUGAnrikefon
Anrikefon is a novel peripherally KOR agonist independently developed in China. In this study, anrikefon will be administered intravenously at a dose of 1 μg/kg, 15 minutes before the end of surgery.
DRUGNalbuphine
Nalbuphine is a traditional central KOR agonist with mixed μ-opioid receptor antagonist activity. In this study, nalbuphine will be administered intravenously at a dose of 0.1 mg/kg, 15 minutes before the end of surgery.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for ophthalmic surgery under general anesthesia. * Aged 18 to 70 years. * With American Society of Anesthesiologists (ASA) physical status I to III. * Body mass index (BMI) between 18 and 30 kg/m² * Agree to participate in the trial and provide written informed consent.
Exclusion criteria
* History of cardiovascular or cerebrovascular events within the past 6 months, including unstable angina, ischemic myocardial infarction, or heart failure; or current presence of uncontrolled hypertension (\>180/110 mmHg), aneurysm, or severe cardiac arrhythmia. * Severe respiratory diseases such as pulmonary fibrosis, severe pulmonary abscess, cor pulmonale, or advanced chronic obstructive pulmonary disease (COPD). * Significant neurological disorders such as brain injury or seizures, as well as severe psychiatric illnesses. * Known allergy to kappa opioid receptor agonists or to general anesthetic agents used in this study. * Current peptic ulcer disease, gastrointestinal bleeding, or known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs), such as flurbiprofen axetil or paracetamol. * Prior use of opioid or non-opioid analgesics, with the last administration occurring within five half-life periods of the drug. * Continuous use of opioid analgesics for more than 10 days within the 3 months prior to screening. * Use of drugs with unknown half-life periods that may affect analgesic efficacy within 14 days before randomization. * History of major surgery within the past 3 months that may interfere with postoperative pain assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative pain severity at rest during the first 6 hours after surgery, measured with the Numeric Rating Scale (0-10, higher scores = worse pain) | In the PACU and at 1 , 2 , 4 and 6 hours after surgery | Pain intensity at rest is recorded with the Numeric Rating Scale (NRS: 0 = no pain, 10 = worst possible pain). The area under the curve (AUC) for these scores will be calculated with the trapezoidal rule, using assessments performed in the PACU and at 1 , 2 , 4 and 6 hours post-operatively. A higher AUC indicates greater cumulative pain over the 6-hour period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity at rest and during eye movement, measured with the Numeric Rating Scale (0-10, higher scores = worse pain) | In the PACU and at 1, 2, 4, 6, 12 and 24 hours, as well as 1 week and 1 month postoperatively | Participants rate their pain intensity at rest and again during voluntary eye movement using the Numeric Rating Scale (NRS: 0 = no pain, 10 = worst possible pain). Assessments are performed in the PACU and at 1, 2, 4, 6, 12, 24 hours, 1 week, and 1 month post-operatively. Higher scores indicate greater pain. |
| Cumulative pain severity during eye movement (0-6 hours) and at rest/during eye movement (0-12 hours and 0-24 hours), measured with the Numeric Rating Scale | In the PACU and at 1, 2, 4, 6, 12, and 24 hours postoperatively | The area under the curve (AUC) is computed with the trapezoidal rule, multiplying the average Numeric Rating Scale within each interval by its duration and summing the products; a higher AUC indicates greater cumulative pain. |
| 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 | At 6, 12, and 24 hours postoperatively | In-hospital, participants with resting NRS ≥4 will receive intravenous flurbiprofen axetil 1 mg/kg. Additional doses can be given if ≥3 hours have passed since the previous flurbiprofen dose and ≥1 hour since the last study drug. Breakthrough pain (NRS ≥7) may be treated immediately. Out-of-hospital, participants with resting NRS ≥4 will receive paracetamol 500 mg per dose, up to 2 g per day. |
| Percentage of patients not requiring rescue analgesics | At 6, 12, and 24 hours postoperatively | During the 6-, 12-, and 24-hour postoperative periods, each patient's use of rescue analgesics (flurbiprofen axetil or paracetamol) is recorded. Patients not receiving rescue analgesics are classified as 'not used,' and the percentage is calculated for each group to evaluate postoperative analgesia adequacy. |
| Satisfaction score of analgesia within 24 hours postoperatively | Within 24 hours postoperatively | A trained study assistant assessed satisfaction score of analgesia at rest using a 0 to 10 NRS scale, where 0 indicates 'completely dissatisfied' and 10 indicates 'completely satisfied.' |
| Emergence time | Through surgery completion, an average of 1 hour. | Emergence time is defined as the interval from stopping anesthetics to eye opening or following simple commands. |
| PACU stay time | Through surgery completion, an average of 2 hours. | PACU stay time is defined as the duration from arrival in PACU to the time of a modified Aldrete score of 9 or 10. |
| Time to first ambulation | Through surgery completion, an average of 24 hours. | Time to first ambulation is defined as the interval from the completion of surgery to the patient's first episode of spontaneous mobilization (i.e., getting out of bed and initiating independent movement). |
| Postoperative hospital stay | Through surgery completion, an average of 24 hours | Postoperative hospital stay (or in-hospital stay for day-surgery patients) is defined as the interval from the completion of surgery to formal discharge from the hospital. |
| Incidence of postoperative complications in the PACU and within 24 hours postoperatively | In the PACU and within 24 hours postoperatively | All assessments of adverse events and medication records will be conducted under double-blind conditions, with evaluators blinded to participant group assignment. The incidence of adverse events will be calculated based on the total number of enrolled participants in each group. |
| Postoperative 24-hour recovery quality assessed using the 15-item Quality of Recovery questionnaire (QoR-15) | At 24 hours postoperatively | Postoperative recovery was assessed using the QoR-15 questionnaire. |
| Intraocular pressure (IOP) [mmHg] | At 24 hours, 1 week, and 1 month postoperatively | Measured with non-contact tonometer; higher values indicate elevated IOP. |
| Orbital pressure [digital palpation grade] | At 24 hours, 1 week, and 1 month postoperatively | Graded by single examiner via digital palpation. |
| Uncorrected visual acuity (UCVA) [LogMAR] | At 24 hours, 1 week, and 1 month postoperatively | Assessed with standard LogMAR chart; lower LogMAR indicates better acuity. |
| Best-corrected visual acuity (BCVA) [LogMAR] | At 24 hours, 1 week, and 1 month postoperatively | Assessed with standard LogMAR chart after refraction; lower LogMAR indicates better acuity. |
Countries
China
Contacts
CONTACTXiaoliang Gan, PhD
CONTACTYanling Zhu, MD
Outcome results
None listed