Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery
NCT ID: NCT07269106
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE4
204 participants
INTERVENTIONAL
2026-01-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The Anrikefon Group
Intravenous injection of Anrikefon 1 μg/kg will be administered 15 minutes before the end of surgery
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.
The Nalbuphine Group
Intravenous injection of nalbuphine 0.1 mg/kg will be administered 15 minutes before the end of surgery
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaoliang Gan
Director of the Department of Anesthesiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
The Affiliated Hospital of Yunnan University
Kunming, Yunnan, China
Eye & ENT Hospital of Fudan University
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Xiaoliang Gan, MD, PhD
Role: primary
Yanling Zhu, MD
Role: backup
Guoning Su, MD, PhD
Role: primary
Ying Qu
Role: backup
Yuan Han, MD, PhD
Role: primary
Rui Xu
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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/s41467-025-60013-y.
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.
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.
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.
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.
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.
Li J, Ye H, Shen W, Chen Q, Lin Y, Gan X. Retrospective analysis of risk factors of postoperative nausea and vomiting in patients undergoing ambulatory strabismus surgery via general anaesthesia. Indian J Anaesth. 2020 May;64(5):375-382. doi: 10.4103/ija.IJA_16_20. Epub 2020 May 1.
Ye H, Lian X, Chen R, Zhu Y, Chen H, Huang J, Xie L, Ma W, Yang H, Guo W. Intraoperative administration of intravenous flurbiprofen axetil with nalbuphine reduces postoperative pain after orbital decompression: a single-center, prospective randomized controlled trial. J Pain Res. 2019 Feb 14;12:659-665. doi: 10.2147/JPR.S187020. eCollection 2019.
Ye Z, Zhu Y, Zhang R, Wang Y, Huang J, Gan X. Effect of Multimodal Preemptive Analgesia of Flurbiprofen Axetil, Nalbuphine, and Retrobulbar Block on Postoperative Pain and Enhanced Recovery in Patients Undergoing Oculoplastic Day Surgery: A Prospective, Randomized, Double-Blinded Study. Ophthalmic Plast Reconstr Surg. 2023 May-Jun 01;39(3):260-265. doi: 10.1097/IOP.0000000000002308. Epub 2023 Jan 24.
Charlson ES, Feng PW, Bui A, Grob S, Tao JP. Opioid Prescribing Patterns Among American Society of Ophthalmic Plastic and Reconstructive Surgery Members in the Medicare Part D Database. Ophthalmic Plast Reconstr Surg. 2019 Jul/Aug;35(4):360-364. doi: 10.1097/IOP.0000000000001266.
Shanthanna H, Ladha KS, Kehlet H, Joshi GP. Perioperative Opioid Administration. Anesthesiology. 2021 Apr 1;134(4):645-659. doi: 10.1097/ALN.0000000000003572.
Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
Zhang L, Shu R, Zhao Q, Li Y, Wang C, Wang H, Yu Y, Wang G. Preoperative But Not Postoperative Flurbiprofen Axetil Alleviates Remifentanil-induced Hyperalgesia After Laparoscopic Gynecological Surgery: A Prospective, Randomized, Double-blinded, Trial. Clin J Pain. 2017 May;33(5):435-442. doi: 10.1097/AJP.0000000000000416.
Rohi A, Olofsson MET, Jakobsson JG. Ambulatory anesthesia and discharge: an update around guidelines and trends. Curr Opin Anaesthesiol. 2022 Dec 1;35(6):691-697. doi: 10.1097/ACO.0000000000001194. Epub 2022 Oct 3.
Raeder J. Procedure-specific and patient-specific pain management for ambulatory surgery with emphasis on the opioid crisis. Curr Opin Anaesthesiol. 2020 Dec;33(6):753-759. doi: 10.1097/ACO.0000000000000922.
Fan ZG, Zhang DD, Li ZW, Yang Y, Lin XF. Outpatient Surgery in Zhongshan Ophthalmic Center: Promise and Problems. Chin Med J (Engl). 2017 Jul 5;130(13):1623-1624. doi: 10.4103/0366-6999.208237. No abstract available.
Zhu Y, Li Z, Chen W, Fan P, Yang S, Liu X, Guo W, Gan X. Incidence and Risk Factors of Moderate to Severe Postoperative Pain Following the Placement of Primary and Secondary Orbital Implants: A Prospective Observational Study. Ophthalmic Plast Reconstr Surg. 2021 Jan-Feb 01;37(1):27-32. doi: 10.1097/IOP.0000000000001664.
Ye H, Chen R, Lian X, Huang J, Mao Y, Lu R, Ai S, Ma W, Lin J, Yang H, Guo W. Risk factors associated with postoperative pain and discomfort in oculoplastic surgery with general anesthesia: a prospective study. J Pain Res. 2018 Feb 21;11:407-415. doi: 10.2147/JPR.S156104. eCollection 2018.
Henzler D, Kramer R, Steinhorst UH, Piepenbrock S, Rossaint R, Kuhlen R. Factors independently associated with increased risk of pain development after ophthalmic surgery. Eur J Anaesthesiol. 2004 Feb;21(2):101-6. doi: 10.1017/s0265021504002042.
Lesin M, Sundov ZD, Jukic M, Puljak L. Postoperative pain in complex ophthalmic surgical procedures: comparing practice with guidelines. Pain Med. 2014 Jun;15(6):1036-42. doi: 10.1111/pme.12433. Epub 2014 Mar 25.
Fregoso G, Wang A, Tseng K, Wang J. Transition from Acute to Chronic Pain: Evaluating Risk for Chronic Postsurgical Pain. Pain Physician. 2019 Sep;22(5):479-488.
Tan Z, Dong Y, Li Q. Dynamics of Acute Postsurgical Pain over the Last Decade: A Bibliometric Analysis. Pain Res Manag. 2022 Nov 7;2022:8090209. doi: 10.1155/2022/8090209. eCollection 2022.
Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIT2025115
Identifier Type: -
Identifier Source: org_study_id