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AzTrials

Ophthalmic SurgeryPhase 4NCT07269106

Efficacy and Safety of Anrikefon for Postoperative Analgesia in Ophthalmic Surgery

A Phase 4 study testing Anrikefon and Nalbuphine in people with Ophthalmic Surgery and Postoperative Pain Management, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Anrikefon and Nalbuphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
3 sitesChina
Study dates
22 Jan 2026to 31 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoliang Gan, PhD contact

0086-13688893908

ganxl@mail.sysu.edu.cn

Yanling Zhu, MD contact

0086-18898600243

zhuyling8@mail.sysu.edu.cn

China3 sites, 3 recruiting

  • Zhongshan Ophthalmic Center, Sun Yat-Sen University

    Guangzhou, Guangdong, 510060

    Xiaoliang Gan, MD, PhD, 0086-13688893908, ganxl@mail.sysu.edu.cn

    Yanling Zhu, MD, 0086-18898600243, zhuyling8@mail.sysu.edu.cn

    Recruiting

  • The Affiliated Hospital of Yunnan University

    Kunming, Yunnan, 650000

    Guoning Su, MD, PhD, 0086-18687107829, suguoning18@163.com

    Ying Qu, 0086-15987106841, quyanpaopao@163.com

    Not yet recruiting

  • Eye & ENT Hospital of Fudan University

    Shanghai, 200031

    Yuan Han, MD, PhD, 0086-13801616119, yuan.han@fdeent.org

    Rui Xu, 0086-17701756327, xurui19861221@126.com

    Not yet recruiting

Other trials in China

About this study

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

Read more
  • 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.
Being tested
Anrikefon, Nalbuphine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnrikefonDrug

    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.

  • NalbuphineDrug

    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.

Study groups in NCT07269106
Study groupRoleWhat they receive
The Anrikefon GroupExperimentalIntravenous injection of Anrikefon 1 μg/kg will be administered 15 minutes before the end of surgery
Receives: Drug: Anrikefon
The Nalbuphine GroupActive comparatorIntravenous injection of nalbuphine 0.1 mg/kg will be administered 15 minutes before the end of surgery
Receives: Drug: Nalbuphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (15)

  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.

    Measured: In the PACU and at 1, 2, 4, 6, 12 and 24 hours, as well as 1 week and 1 month postoperatively

  2. 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.

    Measured: In the PACU and at 1, 2, 4, 6, 12, and 24 hours postoperatively

  3. 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.

    Measured: At 6, 12, and 24 hours postoperatively

  4. 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.

    Measured: At 6, 12, and 24 hours postoperatively

  5. Satisfaction score of analgesia within 24 hours postoperatively

    A trained study assistant assessed satisfaction score of analgesia at rest using a 0 to 10 NRS scale, where 0 indicates 'completely dissatisfied' and 10 indicates 'completely satisfied.'

    Measured: Within 24 hours postoperatively

  6. Emergence time

    Emergence time is defined as the interval from stopping anesthetics to eye opening or following simple commands.

    Measured: Through surgery completion, an average of 1 hour.

  7. PACU stay time

    PACU stay time is defined as the duration from arrival in PACU to the time of a modified Aldrete score of 9 or 10.

    Measured: Through surgery completion, an average of 2 hours.

  8. Time to first ambulation

    Time to first ambulation is defined as the interval from the completion of surgery to the patient's first episode of spontaneous mobilization (i.e., getting out of bed and initiating independent movement).

    Measured: Through surgery completion, an average of 24 hours.

  9. Postoperative hospital stay

    Postoperative hospital stay (or in-hospital stay for day-surgery patients) is defined as the interval from the completion of surgery to formal discharge from the hospital.

    Measured: Through surgery completion, an average of 24 hours

  10. Incidence of postoperative complications in the PACU and within 24 hours postoperatively

    All assessments of adverse events and medication records will be conducted under double-blind conditions, with evaluators blinded to participant group assignment. The incidence of adverse events will be calculated based on the total number of enrolled participants in each group.

    Measured: In the PACU and within 24 hours postoperatively

  11. Postoperative 24-hour recovery quality assessed using the 15-item Quality of Recovery questionnaire (QoR-15)

    Postoperative recovery was assessed using the QoR-15 questionnaire.

    Measured: At 24 hours postoperatively

  12. Intraocular pressure (IOP) [mmHg]

    Measured with non-contact tonometer; higher values indicate elevated IOP.

    Measured: At 24 hours, 1 week, and 1 month postoperatively

  13. Orbital pressure [digital palpation grade]

    Graded by single examiner via digital palpation.

    Measured: At 24 hours, 1 week, and 1 month postoperatively

  14. Uncorrected visual acuity (UCVA) [LogMAR]

    Assessed with standard LogMAR chart; lower LogMAR indicates better acuity.

    Measured: At 24 hours, 1 week, and 1 month postoperatively

  15. Best-corrected visual acuity (BCVA) [LogMAR]

    Assessed with standard LogMAR chart after refraction; lower LogMAR indicates better acuity.

    Measured: At 24 hours, 1 week, and 1 month postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start22 Jan 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07269106
Sponsor's protocol ID
IIT2025115
Status last verified
Mar 2026
First submitted
17 Nov 2025
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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/s41467-025-60013-y.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35645576

  • 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.

    PubMed 32724245

  • 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.

    PubMed 30863138

  • 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.

    PubMed 36727809

  • 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.

    PubMed 30439721

  • Shanthanna H, Ladha KS, Kehlet H, Joshi GP. Perioperative Opioid Administration. Anesthesiology. 2021 Apr 1;134(4):645-659. doi: 10.1097/ALN.0000000000003572.

    PubMed 32991672

  • 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.

    PubMed 28403427

  • 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.

    PubMed 27518488

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anrikefon and Nalbuphine in people with Ophthalmic Surgery and Postoperative Pain Management, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoliang Gan, PhD (0086-13688893908, ganxl@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07269106, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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