Anrikefon versus nalbuphine for pain control after eye surgery

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery: A Multicenter, Randomized, Parallel-Control, Non-Inferiority Trial

This trial will test whether Anrikefon provides pain relief as well as nalbuphine for adults having eye surgery under general anesthesia.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (other)
• Locations: 3 sites (Guangzhou, Guangdong and 2 other locations)
• Trial ID: NCT07269106 on ClinicalTrials.gov

What this trial studies

Adults aged 18–70 undergoing ophthalmic surgery under general anesthesia will receive an intravenous dose of either Anrikefon or nalbuphine during the perioperative period and will be followed for pain, side effects, and recovery. The phase 4 interventional comparison is designed to determine whether Anrikefon is not inferior to nalbuphine for postoperative analgesia while producing fewer central side effects such as sedation or dizziness. Researchers will record pain scores, adverse events, and recovery metrics including time to discharge after day-surgery procedures, with follow-up assessments to capture safety and recovery outcomes. Results will help determine if Anrikefon can offer effective and safer perioperative pain management for ophthalmic day-surgery patients.

Who should consider this trial

Good fit: Adults 18–70 years old with ASA physical status I–III, BMI 18–30 kg/m², scheduled for ophthalmic surgery under general anesthesia who can give written informed consent are ideal candidates.

Not a fit: Patients with recent cardiovascular or cerebrovascular events, severe respiratory disease, major neurological or psychiatric disorders, known allergy to kappa opioid agonists or the anesthetic agents used in the study, or other listed exclusion conditions (such as active peptic ulcer disease) are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, Anrikefon could provide effective postoperative pain relief with fewer central nervous system side effects and potentially faster recovery and discharge for eye surgery patients.

How similar studies have performed: Nalbuphine is an established option for perioperative analgesia, while kappa-opioid agents like Anrikefon have been explored in other settings but have limited published data specifically in ophthalmic day-surgery.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong and 2 other locations

• Zhongshan Ophthalmic Center, Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)
• The Affiliated Hospital of Yunnan University — Kunming, Yunnan, China (NOT_YET_RECRUITING)
• Eye & ENT Hospital of Fudan University — Shanghai, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Xiaoliang Gan, PhD

Conditions: Ophthalmic Surgery, Postoperative Pain Management, Opioid Analgesia