Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Anrikefon
DrugAnrikefon 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.
Nalbuphine
DrugNalbuphine 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.
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: The Anrikefon GroupExperimental treatment 1 intervention
Group B: The Nalbuphine GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative pain severity at rest during the first 6 hours after surgery, measured with the Numeric Rating Scale (0-10, higher scores = worse pain)
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.
Time frame
In the PACU and at 1 , 2 , 4 and 6 hours after surgerySecondary outcomes
1
Pain severity at rest and during eye movement, measured with the Numeric Rating Scale (0-10, higher scores = worse pain)
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.
Time frame
In the PACU and at 1, 2, 4, 6, 12 and 24 hours, as well as 1 week and 1 month postoperatively2
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
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.
Time frame
In the PACU and at 1, 2, 4, 6, 12, and 24 hours postoperatively3
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
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.
Time frame
At 6, 12, and 24 hours postoperatively4
Percentage of patients not requiring rescue analgesics
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.
Time frame
At 6, 12, and 24 hours postoperativelyOther outcomes
1
Mechanical pain threshold of the operative eye at 2 and 24 hours postoperatively
Quantitative assessment around the periocular area of the operative eye using electronic Von Frey test.
Time frame
At 2 and 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov