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Recruiting NCT07269106

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

Phase IV Interventional Ophthalmic Surgery Postoperative Pain Management Opioid Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anrikefon, Nalbuphine.
Who it may be relevant to
Registry conditions: Ophthalmic Surgery, Postoperative Pain Management, Opioid Analgesia. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Anrikefon
    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.
  • Drug Nalbuphine
    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.

Primary outcome measures

  • Cumulative pain severity at rest during the first 6 hours after surgery, measured with the Numeric Rating Scale (0-10, higher scores = worse pain) [Time frame: In the PACU and at 1 , 2 , 4 and 6 hours after surgery]
Secondary outcome measures (12)
  • Pain severity at rest and during eye movement, measured with the Numeric Rating Scale (0-10, higher scores = worse pain) [Time frame: 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 [Time frame: 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 [Time frame: At 6, 12, and 24 hours postoperatively]
  • Percentage of patients not requiring rescue analgesics [Time frame: At 6, 12, and 24 hours postoperatively]
  • Satisfaction score of analgesia within 24 hours postoperatively [Time frame: Within 24 hours postoperatively]
  • Emergence time [Time frame: Through surgery completion, an average of 1 hour.]
  • PACU stay time [Time frame: Through surgery completion, an average of 2 hours.]
  • Time to first ambulation [Time frame: Through surgery completion, an average of 24 hours.]
  • Postoperative hospital stay [Time frame: Through surgery completion, an average of 24 hours]
  • Incidence of postoperative complications in the PACU and within 24 hours postoperatively [Time frame: In the PACU and within 24 hours postoperatively]
  • Postoperative 24-hour recovery quality assessed using the 15-item Quality of Recovery questionnaire (QoR-15) [Time frame: At 24 hours postoperatively]
  • Intraocular pressure (IOP) [mmHg] [Time frame: At 24 hours, 1 week, and 1 month postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 3 centers
  • Zhongshan Ophthalmic Center, Sun Yat-Sen University — Guangzhou
  • The Affiliated Hospital of Yunnan University — Kunming
  • Eye & ENT Hospital of Fudan University — Shanghai

Publications

  • An introductory note to the CHMP guidelines: choice of the non-inferiority margin and data monitoring committees by David Brown, Peter Volkers and Simon Day, Statistics in Medicine 2006; 25:1623-1627. Stat Med. 2007 Jan 15;26(1):230-3; author reply 234-5. doi: 10.1002/sim.2665. No abstract available. PMID 16900566
  • Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802. PMID 23268518
  • Zhong Y, Xu Y, Lei Q, Yang M, Wang S, Hu X, Xie H, Li Y, Qin Z, Gu Z, Zhang J, Wang Y, Wu J, Wang H, Ming Y, Xia Z, Zhai H, Jiang K, Zhang P, Wang Z, Wang L, Li L, Cheng Z, Jiang H, Wang G, Chen J, Zhao Z, Chen X, Yan M. HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials. Nat Commun. 2025 May 24;16(1):4830. doi: 10.1038/s41467-025-60 PMID 40413233
  • Wang X, Gou X, Yu X, Bai D, Tan B, Cao P, Qian M, Zheng X, Wang H, Tang P, Zhang C, Ye F, Ni J. Antinociceptive and Antipruritic Effects of HSK21542, a Peripherally-Restricted Kappa Opioid Receptor Agonist, in Animal Models of Pain and Itch. Front Pharmacol. 2021 Nov 16;12:773204. doi: 10.3389/fphar.2021.773204. eCollection 2021. PMID 34867403
  • Shao R, Wang HY, Ruan ZR, Jiang B, Yang DD, Hu Y, Xu YC, Yang JT, Gao W, Zhao WY, Yan M, Lou H. Phase I clinical trial evaluating the safety, tolerance, pharmacokinetics and pharmacodynamics of HSK21542 injection in healthy volunteers. Basic Clin Pharmacol Toxicol. 2024 Dec;135(6):743-754. doi: 10.1111/bcpt.14094. Epub 2024 Oct 13. PMID 39397291
  • Gou X, Chen Y, Ye Q, Meng Q, Jia Y, Li P, Wang Q, Wang J, Zhang C, Wang J, Dong Y. Preclinical evaluation of abuse potential of the peripherally-restricted kappa opioid receptor agonist HSK21542. Regul Toxicol Pharmacol. 2024 Dec;154:105731. doi: 10.1016/j.yrtph.2024.105731. Epub 2024 Oct 23. PMID 39455048
  • Wang K, Chen M, Xu F, Zhang F, Liu L, Liu X, Sun Z, Zhao W, Wang Y, Yang J. Population pharmacokinetic modeling and exposure-response analysis of anrikefon: insights and implications in clinical analgesia. Expert Rev Clin Pharmacol. 2025 Jan-Feb;18(1-2):77-88. doi: 10.1080/17512433.2025.2449983. Epub 2025 Jan 23. PMID 39825476
  • Zhang XM, Lun MH, Du W, Ma F, Huang ZQ. The kappa-Opioid Receptor Agonist U50488H Ameliorates Neuropathic Pain Through the Ca2+/CaMKII/CREB Pathway in Rats. J Inflamm Res. 2022 May 23;15:3039-3051. doi: 10.2147/JIR.S327234. eCollection 2022. PMID 35645576

Identifiers

NCT: NCT07269106 · IIT2025115

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗