Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

NCT07269106 | Recruiting Phase 4

• 1 other identifier: IIT2025115
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 3

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.

Conditions

Ophthalmic Surgery; Postoperative Pain Management; Opioid Analgesia

Outcome Measures

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.

  In the PACU and at 1 , 2 , 4 and 6 hours after surgery

Secondary Outcomes (15)

• 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

• 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

• 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

• Percentage of patients not requiring rescue analgesics

  At 6, 12, and 24 hours postoperatively

• Satisfaction score of analgesia within 24 hours postoperatively

  Within 24 hours postoperatively

Other Outcomes (1)

• Mechanical pain threshold of the operative eye at 2 and 24 hours postoperatively

  At 2 and 24 hours postoperatively

Study Arms (2)

The Anrikefon Group

EXPERIMENTAL

Intravenous injection of Anrikefon 1 μg/kg will be administered 15 minutes before the end of surgery

Drug: Anrikefon

The Nalbuphine Group

ACTIVE COMPARATOR

Intravenous injection of nalbuphine 0.1 mg/kg will be administered 15 minutes before the end of surgery

Drug: Nalbuphine

Interventions

Anrikefon DRUG

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.

The Anrikefon Group

Nalbuphine DRUG

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.

The Nalbuphine Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (3)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

The Affiliated Hospital of Yunnan University

Kunming, Yunnan, 650000, China

NOT YET RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

NOT YET RECRUITING

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MeSH Terms

Interventions

Nalbuphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Xiaoliang Gan, PhD

CONTACT

0086-13688893908; ganxl@mail.sysu.edu.cn

Yanling Zhu, MD

CONTACT

0086-18898600243; zhuyling8@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Anesthesiology

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 8, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)